| 2025-01-03 |
Class II
|
Ongoing |
Z-1068-2025 |
Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software … |
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Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue. |
| 2025-01-03 |
Class II
|
Ongoing |
Z-1067-2025 |
Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA … |
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Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue. |
| 2024-12-12 |
Class II
|
Ongoing |
Z-1073-2025 |
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimul… |
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Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed positio… |
| 2024-12-12 |
Class II
|
Ongoing |
Z-1072-2025 |
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimula… |
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Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed positio… |
| 2021-12-02 |
Class II
|
Terminated |
Z-0532-2022 |
Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode… |
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A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. If the tubing beco… |
| 2020-11-12 |
Class II
|
Terminated |
Z-0535-2021 |
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in pati… |
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During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated. |
| 2020-09-28 |
Class II
|
Terminated |
Z-0462-2021 |
VNS Therapy¿ AspireSR¿ Generator |
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Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy progra… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2464-2020 |
Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107 |
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The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2463-2020 |
Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2462-2020 |
1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2461-2020 |
1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2460-2020 |
3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2459-2020 |
3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285 |
— |
XXX |
| 2020-04-24 |
Class II
|
Terminated |
Z-2458-2020 |
1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2457-2020 |
Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2456-2020 |
Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2455-2020 |
Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2454-2020 |
Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2453-2020 |
Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2452-2020 |
Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2451-2020 |
Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2450-2020 |
Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2449-2020 |
Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2448-2020 |
Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2447-2020 |
Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2446-2020 |
Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2445-2020 |
Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert Label:050434000/ 00803622123207 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2444-2020 |
Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert Label:050432000 / 00803622123184 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-04-24 |
Class II
|
Terminated |
Z-2443-2020 |
Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153 |
— |
The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially aff… |
| 2020-02-24 |
Class II
|
Terminated |
Z-1498-2020 |
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat ex… |
— |
The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination. |
| 2020-02-04 |
Class II
|
Ongoing |
Z-1563-2020 |
VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators. |
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False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-ses… |