| 2023-05-10 |
Class I
|
Ongoing |
Z-1823-2023 |
ICD CROME VR MRI DF4, Model Number DVPC3D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1822-2023 |
ICD CROME VR MRI IS1 DF1, Model Number DVPC3D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1821-2023 |
ICD COBALT VR MRI DF4, Model Number DVPB3D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1820-2023 |
ICD COBALT VR MRI IS1 DF1, Model Number DVPB3D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1819-2023 |
ICD COBALT XT VR MRI DF4, Model Number DVPA2D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1818-2023 |
ICD COBALT XT VR MRI IS1 DF1, Model Number DVPA2D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1817-2023 |
ICD-VR DVME3D4 MIRRO MRI, Model Number DVME3D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1816-2023 |
ICD-VR DVME3D1 MIRRO MRI, Model Number DVME3D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1815-2023 |
ICD-VR DVMD3D4 PRIMO MRI, Model Number DVMD3D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1814-2023 |
ICD-VR DVMD3D1 PRIMO MRI, Model Number DVMD3D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1813-2023 |
ICD-VR DVMC3D4 EVERA MRI S DF4 GLOB, Model Number DVMC3D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1812-2023 |
ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1, Model Number DVMC3D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1811-2023 |
ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1810-2023 |
ICD-VR DVMB2D1 EVERA MRI XT OUS DF1, Model Number DVMB2D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1809-2023 |
ICD-VR DVMB1D4 EVERA MRI XT DF4 US, Model Number DVMB1D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1808-2023 |
ICD-VR VISIA MRI AF S US/OUS DF4, Model Number DVFC3D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1807-2023 |
ICD-VR DVFC3D1 VISIA AF MRI S OUS/US DF1, Model Number DVFC3D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1806-2023 |
ICD-VR VISIA MRI AF XT OUS DF4, Model Number DVFB2D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1805-2023 |
ICD-VR DVFB2D1 VISIA AF MRI XT OUS DF1, Model Number DVFB2D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1804-2023 |
ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1803-2023 |
ICD-VR DVFB1D1 VISIA AF MRI US DF1, Model Number DVFB1D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1802-2023 |
ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1801-2023 |
ICD-VR DVEX2E4 EV ICD OUS EV4, Model Number DVEX2E4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1800-2023 |
ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1799-2023 |
ICD-VR DVBC3D1 EVERA S IS1/DF1 GLOB, Model Number DVBC3D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1798-2023 |
ICD-VR DVBB2D4 EVERA XT DF4 INTL, Model Number DVBB2D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1797-2023 |
ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1796-2023 |
ICD-VR DVBB1D4 EVERA XT DF4 US, Model Number DVBB1D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1795-2023 |
ICD-VR DVBB1D1 EVERA XT IS1/DF1 US, Model Number DVBB1D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1794-2023 |
ICD-VR VISIA AF S US/OUS DF4, Model Number DVAC3D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1793-2023 |
ICD-VR VISIA AF S US/OUS IS1/DF1, Model Number DVAC3D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1792-2023 |
ICD-VR VISIA AF XT OUS DF4, Model Number DDVAB2D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1791-2023 |
ICD-VR VISIA AF XT OUS IS1/DF1, Model Number DVAB2D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1790-2023 |
ICD-VR DVAB1D4 VISIA AF US DF4, Model Number DVAB1D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1789-2023 |
ICD-VR DVAB1D1 VISIA AF US IS1/DF1, Model Number DVAB1D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1788-2023 |
CRTD CROME HF QUAD MRI IS4 DF4, Model Number DTPC2QQ; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1787-2023 |
CRTD CROME HF QUAD MRI IS4 DF1, Model Number DTPC2Q1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1786-2023 |
CRTD CROME HF MRI IS1 DF4, Model Number DTPC2D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1785-2023 |
CRTD CROME HF MRI IS1 DF1, Model Number DTPC2D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1784-2023 |
CRTD COBALT HF QUAD MRI IS4 DF4, Model Number DTPB2QQ ; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1783-2023 |
CRTD COBALT HF QUAD MRI IS4 DF1, Model Number DTPB2Q1 ; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1782-2023 |
CRTD COBALT HF MRI IS1 DF4, Model Number DTPB2D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1781-2023 |
CRTD COBALT HF MRI IS1 DF1, Model Number DTPB2D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1780-2023 |
ICD COBALT XT HF QUAD OUS, Model Number DTPA2QQG; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1779-2023 |
CRTD COBALT XT HF QUAD MRI IS4 DF4, Model Number DTPA2QQ; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1778-2023 |
CRTD COBALT XT HF QUAD MRI IS4 DF1, Model Number DTPA2Q1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1777-2023 |
CRTD COBALT XT HF MRI IS1 DF4, Model Number DTPA2D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1776-2023 |
CRTD DTPA2D1PX COBALT XT HF QUAD OUS, Model Number DTPA2D1PX; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1775-2023 |
CRTD DTPA2D1G COBALT XT HF QUAD OUS, Model Number DTPA2D1G; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1774-2023 |
CRTD COBALT XT HF MRI IS1 DF1, Model Number DTPA2D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1773-2023 |
CRTD DTMC2QQ COMPIA MRI QUAD OUS DF4, Model Number DTMC2QQ; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1772-2023 |
CRTD DTMC2D4 COMPIA MRI OUS DF4, Model Number DTMC2D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1771-2023 |
CRTD DTMC2D1 COMPIA MRI OUS DF1, Model Number DTMC2D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1770-2023 |
CRTD DTMC1QQ COMPIA MRI QUAD US DF4, Model Number DTMC1QQ; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1769-2023 |
CRTD DTMC1D1 COMPIA MRI US DF1, Model Number DTMC1D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1768-2023 |
CRTD DTMB2QQ AMPLIA MRI QUAD OUS DF4, Model Number DTMB2QQ; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1767-2023 |
CRTD DTMB2Q1 AMPLIA MRI QUAD OUS DF1, Model Number DTMB2Q1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1766-2023 |
CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1765-2023 |
CRTD DTMB2D1 AMPLIA MRI OUS DF1, Model Number DTMB2D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1764-2023 |
CRTD DTMB1QQ AMPLIA MRI QUAD US DF4, Model Number DTMB1QQ; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1763-2023 |
CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1762-2023 |
CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1761-2023 |
CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1760-2023 |
CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1759-2023 |
CRTD DTMA2Q1 CLARIA MRI QUAD OUS DF1, Model Number DTMA2Q1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1758-2023 |
CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1757-2023 |
CRTD DTMA2D1 CLARIA MRI OUS DF1, Model Number DTMA2D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1756-2023 |
CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1755-2023 |
CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1754-2023 |
CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1753-2023 |
CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1752-2023 |
CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1751-2023 |
CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1750-2023 |
CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1749-2023 |
CRT-D DTBC2D1 BRAVA IS1/DF1 INTL, Model Number DTBC2D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1748-2023 |
CRT-D DTBB2QQ VIVA QUAD S IS4/DF4 INTL, Model Number DTBB2QQ; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1747-2023 |
CRT-D DTBB2Q1 VIVA QUAD S IS4/DF1 INTL, Model Number DTBB2Q1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1746-2023 |
CRT-D DTBB2D4 VIVA S IS1/DF4 INTL, Model Number DTBB2D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1745-2023 |
CRT-D DTBB2D1 VIVA S IS1/DF1 INTL, Model Number DTBB2D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1744-2023 |
CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1743-2023 |
CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1742-2023 |
CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1741-2023 |
CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1740-2023 |
CRT-D VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1739-2023 |
CRT-D DTBA2QQ VIVA QUAD XT IS4/DF4 INTL, Model Number DTBA2QQ; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1738-2023 |
CRT-D DTBA2Q1 VIVA QUAD XT IS4/DF1 INTL, Model Number DTBA2Q1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1737-2023 |
CRT-D DTBA2D4 VIVA XT IS1/DF4 INTL, Model Number DTBA2D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1736-2023 |
CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1G; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1735-2023 |
CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL, Model Number DTBA2D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1734-2023 |
CRTD VIVA QUAD XT CUST PARY GOLD, Model Number DTBA1QQPG; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1733-2023 |
CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1732-2023 |
CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1731-2023 |
CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1730-2023 |
CRT-D DTBA1D1G DF1 VIVA XT US GOLD CTD, Model Number DTBA1D1G; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1729-2023 |
CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1728-2023 |
ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1727-2023 |
ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1726-2023 |
ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1725-2023 |
ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1724-2023 |
ICD DDPA2D4G COBALT XT DR MRI DF4 GOLD, Model Number DDPA2D4G; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1723-2023 |
ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1722-2023 |
ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1721-2023 |
ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1720-2023 |
ICD-DR DDME3D4 MIRRO MRI, Model Number DDME3D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1719-2023 |
ICD-DR DDME3D1 MIRRO MRI, Model Number DDME3D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1718-2023 |
ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1717-2023 |
ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1716-2023 |
ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1715-2023 |
ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1714-2023 |
ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT, Model Number DDMB2D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1713-2023 |
ICD-DR DDMB2D1 EVERA MRI XT OUS DF1, Model Number DDMB2D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1712-2023 |
ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1711-2023 |
ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1710-2023 |
ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1709-2023 |
ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1708-2023 |
ICD-DR DDBB2D4 EVERA XT IS1/DF4 INTL, Model Number DDBB2D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1707-2023 |
ICD-DR DDBB2D1 EVERA XT IS1/DF1 INTL, Model Number DDBB2D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1706-2023 |
ICD EVERA XT DR GOLD CTD, Model Number DDBB1D4G; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1705-2023 |
ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2023-05-10 |
Class I
|
Ongoing |
Z-1704-2023 |
ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators |
— |
There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) … |
| 2022-06-22 |
Class I
|
Ongoing |
Z-1490-2022 |
Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model … |
— |
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defib… |
| 2022-06-22 |
Class I
|
Ongoing |
Z-1489-2022 |
Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model … |
— |
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defib… |
| 2022-06-22 |
Class I
|
Ongoing |
Z-1488-2022 |
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Mode… |
— |
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defib… |
| 2022-06-22 |
Class I
|
Ongoing |
Z-1487-2022 |
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Mod… |
— |
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defib… |
| 2022-06-22 |
Class I
|
Ongoing |
Z-1486-2022 |
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, M… |
— |
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defib… |
| 2022-06-22 |
Class I
|
Ongoing |
Z-1485-2022 |
Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR IC… |
— |
There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defib… |
| 2022-04-20 |
Class II
|
Ongoing |
Z-1206-2022 |
The C304-HIS device features a guide wire to access the vein, a valve to reduce blood loss during the implant procedure,… |
— |
The firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility. |
| 2022-04-12 |
Class II
|
Ongoing |
Z-1268-2022 |
Crome Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Crome VR: DVPC3D1, DVPC3… |
— |
Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillato… |
| 2022-04-12 |
Class II
|
Ongoing |
Z-1267-2022 |
Cobalt Models loaded with CareLink SmartSync Device Manager application software D00U005: a) Cobalt XT VR: DVPA2D1, DV… |
— |
Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillato… |
| 2022-01-18 |
Class II
|
Terminated |
Z-0782-2022 |
LINQ II Insertable Cardiac Monitor |
— |
Devices may lose functionality due to susceptibility to moisture ingress. |
| 2021-11-19 |
Class II
|
Terminated |
Z-0464-2022 |
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System. |
— |
There have been reports of stent migration. |
| 2021-11-08 |
Class II
|
Terminated |
Z-0391-2022 |
Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator |
— |
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a c… |
| 2021-11-08 |
Class II
|
Terminated |
Z-0390-2022 |
Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72 |
— |
The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a c… |
| 2021-10-12 |
Class II
|
Ongoing |
Z-0282-2022 |
Medtronic CareLink SmartSync Device Manager application software (D00U005) used by the following Medtronic Cobalt and Cr… |
— |
The processing of collected episode data may fail due to a software error. |
| 2021-09-09 |
Class II
|
Ongoing |
Z-0173-2022 |
C315-HIS Delivery Catheter |
— |
Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter. |
| 2021-06-01 |
Class II
|
Ongoing |
Z-2102-2021 |
Medtronic Reveal LINQ LNQ11 / PA96000 |
— |
Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pau… |
| 2021-05-14 |
Class II
|
Ongoing |
Z-2076-2021 |
Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only |
— |
Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset. |
| 2021-04-07 |
Class II
|
Terminated |
Z-1650-2021 |
Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Pro… |
— |
The device may contain a manufacturing defect of a missing resistance spot weld (RSW). |
| 2021-04-06 |
Class II
|
Ongoing |
Z-1528-2021 |
CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P… |
— |
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the r… |
| 2021-04-06 |
Class II
|
Ongoing |
Z-1527-2021 |
Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also prov… |
— |
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the r… |
| 2021-04-06 |
Class II
|
Ongoing |
Z-1526-2021 |
Implantable cardiac resynchronization therapy pacemakers (CRT-P) - Product Usage: used to treat arrhythmias related to b… |
— |
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the r… |
| 2021-04-06 |
Class II
|
Ongoing |
Z-1525-2021 |
Implantable Pulse Generators - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devi… |
— |
A longevity estimation error may occur in the early years of device life when a unipolar pacing vector is programmed in the right atrial (RA) lead and/or the r… |
| 2021-04-06 |
Class II
|
Ongoing |
Z-1523-2021 |
CRT-P Quad Models (CRT-Ps): a. Percepta CRT-P MRI: W1TR01, W1TR04, W4TR01, W4TR04 b. Serena CRT-P MRI: W1TR02, W1TR05… |
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There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time b… |
| 2021-04-06 |
Class II
|
Ongoing |
Z-1522-2021 |
CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED). |
— |
There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time b… |
| 2021-02-03 |
Class I
|
Ongoing |
Z-1306-2021 |
Implantable cardioverter defibrillators (ICD) with cardiac resynchronization therapy (CRT-D): 1) Viva family: Viva XT C… |
— |
A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EO… |
| 2021-02-03 |
Class I
|
Ongoing |
Z-1305-2021 |
Implantable cardioverter defibrillators (ICD): 1) Evera family: Evera XT DR, Evera S DR, Evera MRI XT DR, Evera MRI S D… |
— |
A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EO… |
| 2020-11-15 |
Class II
|
Terminated |
Z-0928-2021 |
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureSc… |
— |
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function. |
| 2020-11-15 |
Class II
|
Terminated |
Z-0927-2021 |
Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resyn… |
— |
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function. |
| 2020-11-15 |
Class II
|
Terminated |
Z-0926-2021 |
Medtronic COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, MR Conditional implantable cardioverter defibrillator… |
— |
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function. |
| 2020-11-05 |
Class II
|
Ongoing |
Z-1480-2022 |
Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) |
— |
Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements. |
| 2020-06-04 |
Class II
|
Ongoing |
Z-2513-2020 |
Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06 |
— |
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some… |
| 2020-06-04 |
Class II
|
Ongoing |
Z-2512-2020 |
Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05 |
— |
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some… |
| 2020-06-04 |
Class II
|
Ongoing |
Z-2511-2020 |
Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04 |
— |
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some… |
| 2020-06-04 |
Class II
|
Ongoing |
Z-2510-2020 |
Azure S SR MRI, Model Number W3SR01 |
— |
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some… |
| 2020-06-04 |
Class II
|
Ongoing |
Z-2509-2020 |
Azure XT SR MRI, Model Numbers: a) W1SR01 and b) W2SR01 |
— |
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some… |
| 2020-06-04 |
Class II
|
Ongoing |
Z-2508-2020 |
Azure S DR MRI, Model Number W3DR01 |
— |
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some… |
| 2020-06-04 |
Class II
|
Ongoing |
Z-2507-2020 |
Azure XT DR MRI, Model Numbers: a) W1DR01 and b) W2DR01 |
— |
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some… |
| 2020-06-04 |
Class II
|
Ongoing |
Z-2506-2020 |
Patient Connector, Model Number 24967 |
— |
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some… |
| 2020-06-04 |
Class II
|
Ongoing |
Z-2505-2020 |
CareLink SmartSync Device Manager, Model Number 24970A |
— |
There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some… |
| 2020-01-30 |
Class II
|
Ongoing |
Z-1525-2020 |
Medtronic CareLink Encore 29901 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices… |
— |
Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitiv… |
| 2020-01-30 |
Class II
|
Ongoing |
Z-1524-2020 |
Medtronic CareLink 2090 Programmer. Used to interrogate and program Medtronic and Vitatron implantable devices, such as… |
— |
Medtronic Conexus Telemetry has been determined to contain two primary cyber vulnerabilities: improper access control and the cleartext transmission of sensitiv… |