| 2025-09-10 |
Class I
|
Ongoing |
Z-0113-2026 |
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter |
— |
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. |
| 2025-09-10 |
Class I
|
Ongoing |
Z-0112-2026 |
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter |
— |
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. |
| 2025-09-10 |
Class I
|
Ongoing |
Z-0111-2026 |
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter |
— |
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. |
| 2025-09-10 |
Class I
|
Ongoing |
Z-0110-2026 |
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter |
— |
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. |
| 2025-09-10 |
Class I
|
Ongoing |
Z-0109-2026 |
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter |
— |
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. |
| 2025-03-17 |
Class II
|
Ongoing |
Z-1644-2025 |
Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080 |
— |
Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to… |
| 2025-03-17 |
Class II
|
Ongoing |
Z-1643-2025 |
Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080 |
— |
Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to… |
| 2024-03-04 |
Class II
|
Ongoing |
Z-1480-2024 |
Alinity i Anti-HCV Reagent Kit, List Number 08P0521 |
— |
Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential… |
| 2024-03-04 |
Class II
|
Ongoing |
Z-1479-2024 |
ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35 |
— |
Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential… |
| 2023-09-28 |
Class II
|
Ongoing |
Z-0209-2024 |
Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator |
— |
Certain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance and therefore may not have provided accurate result… |
| 2023-06-12 |
Class I
|
Ongoing |
Z-2110-2023 |
Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac). |
— |
There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during procedures in which the ASDS product was used. |
| 2022-06-09 |
Class II
|
Ongoing |
Z-1344-2022 |
Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart … |
— |
When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "… |
| 2022-04-28 |
Class II
|
Terminated |
Z-1213-2022 |
FIRMap" Catheter, 60mm Basket |
— |
Incorrect product labeling. |
| 2022-03-24 |
Class II
|
Ongoing |
Z-0957-2022 |
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile. |
— |
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device. |
| 2022-03-24 |
Class II
|
Ongoing |
Z-0956-2022 |
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile. |
— |
Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device. |
| 2021-11-16 |
Class II
|
Terminated |
Z-0420-2022 |
Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM |
— |
As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured with an incorrect hub and overall length. The devic… |
| 2021-11-09 |
Class II
|
Terminated |
Z-0895-2022 |
Amplatzer Steerable Delivery Sheath |
— |
Instructions for use were updated. |
| 2020-05-22 |
Class II
|
Terminated |
Z-2541-2020 |
TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN … |
— |
High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter |
| 2020-02-28 |
Class II
|
Terminated |
Z-1700-2020 |
Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model… |
— |
Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the p… |