Alameda, CA, US · 8 510(k) clearances · 31 PMAs · 19 recalls (6 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | Class II | Cardiovascular | 3 | 2022-08-18 |
| DQY | Catheter, Percutaneous | Class II | Cardiovascular | 2 | 2026-07-02 |
| MXD | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | Class II | Cardiovascular | 1 | 2025-09-17 |
| SAF | Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter | Class II | Clinical Chemistry | 1 | 2024-05-29 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | Class II | Cardiovascular | 1 | 2022-12-01 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2026-09-02 | P170038-S032 | CentriMag Circulatory Support System | 30-Day Notice | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2026-05-05 | P170038-S031 | CentriMag Circulatory Support System | 30-Day Notice | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2026-05-04 | P170038-S030 | CentriMag Circulatory Support System | Real-Time Process | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2026-04-17 | P170038-S029 | CentriMag Circulatory Support System | Real-Time Process | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2026-02-18 | P170038-S028 | CentriMag Circulatory Support System | 30-Day Notice | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2026-02-03 | P170038-S027 | CentriMag Circulatory Support System | 30-Day Notice | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2025-12-01 | P170038-S025 | CentriMag Circulatory Support System | Normal 180 Day Track No User Fee | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2025-09-29 | P170038-S023 | CentriMag Circulatory Support System | Real-Time Process | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2025-08-21 | P170038-S026 | CentriMag Circulatory Support System | 30-Day Notice | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2025-06-02 | P170038-S024 | CentriMag Circulatory Support System | 30-Day Notice | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2025-02-04 | P170038-S017 | CentriMag Circulatory Support System | Normal 180 Day Track | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2024-11-05 | P170038-S022 | CentriMag Circulatory Support System | 30-Day Notice | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2024-11-01 | P170038-S021 | CentriMag Circulatory Support System | 30-Day Notice | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2024-09-25 | P170038-S020 | CentriMag Circulatory Support System | 30-Day Notice | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2024-07-15 | P170038-S019 | CentriMag Circulatory Support System | Normal 180 Day Track No User Fee | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2024-06-11 | P170038-S018 | CentriMag Circulatory Support System | 30-Day Notice | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2024-05-01 | P170038-S016 | CentriMag Circulatory Support System | 30-Day Notice | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2024-04-24 | P170038-S015 | CentriMag Circulatory Support System | 30-Day Notice | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2024-04-22 | P170038-S014 | CentriMag Circulatory Support System | 30-Day Notice | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2024-01-09 | P170038-S012 | CentriMag Circulatory Support System | Real-Time Process | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2023-09-14 | P170038-S013 | CentriMag Circulatory Support System | Real-Time Process | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2023-03-03 | P170038-S011 | CentriMag Circulatory Support System | 135 Review Track For 30-Day Notice | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2022-05-11 | P170038-S010 | CentriMag Circulatory Support System | 30-Day Notice | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2022-04-01 | P170038-S009 | CentriMag Circulatory Support System | 30-Day Notice | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2021-10-22 | P170038-S008 | CentriMag Circulatory Support System | 135 Review Track For 30-Day Notice | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2021-08-19 | P170038-S007 | CentriMag Circulatory Support System | Normal 180 Day Track No User Fee | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2021-08-05 | P170038-S006 | CentriMag Circulatory Support System | 30-Day Notice | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2020-08-28 | P170038-S005 | CentriMag Circulatory Support System | Normal 180 Day Track No User Fee | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2020-05-22 | P170038-S002 | CentriMag Circulatory Support System | Normal 180 Day Track No User Fee | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2020-04-16 | P170038-S003 | CentriMag Circulatory Support System | 30-Day Notice | DSQ | Ventricular (Assist) Bypass | Unknown |
| 2020-03-20 | P170038-S001 | CentriMag Circulatory Support System | Normal 180 Day Track No User Fee | DSQ | Ventricular (Assist) Bypass | Unknown |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 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… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-07-02 | K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter | DQY | Class II | Cardiovascular |
| 2026-04-24 | K260993 | Amplatzer TorqVue Delivery System | DQY | Class II | Cardiovascular |
| 2025-09-17 | K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000) | MXD | Class II | Cardiovascular |
| 2024-05-29 | K233655 | Lingo Glucose System | SAF | Class II | Clinical Chemistry |
| 2022-12-01 | K222297 | CentriMag Pre-connected Pack | DTZ | Class II | Cardiovascular |
| 2022-08-18 | K221213 | EnSite X EP System | DQK | Class II | Cardiovascular |
| 2021-10-22 | K212061 | EnSite X EP System | DQK | Class II | Cardiovascular |
| 2021-03-11 | K210392 | WorkMate Claris System | DQK | Class II | Cardiovascular |