Abbott
Medical device manufacturer in Saint Paul, MN.
13510(k) clearances
1PMA approvals
40recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261825 | Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterDQY · Special | 07/02/2026SE |
| K260993 | Amplatzer TorqVue Delivery SystemDQY · Special | 04/24/2026SE |
| K251221 | Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)MXD · Traditional | 09/17/2025SE |
| K233655 | Lingo Glucose SystemSAF · Traditional | 05/29/2024SE |
| K222297 | CentriMag Pre-connected PackDTZ · Traditional | 12/01/2022SE |
| K221213 | EnSite X EP SystemDQK · Traditional | 08/18/2022SE |
| K212061 | EnSite X EP SystemDQK · Traditional | 10/22/2021SE |
| K210392 | WorkMate Claris SystemDQK · Special | 03/11/2021SE |
| K192593 | Confirm Rx Insertable Cardiac MonitorMXC · Special | 10/18/2019SE |
| K190167 | MitraClip G4 Steerable Guide CatheterDRA · Special | 05/29/2019SE |
| K182981 | Confirm Rx Insertable Cardiac MonitorMXC · Traditional | 03/29/2019SE |
| K183128 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2DQK · Special | 12/12/2018SE |
| K182644 | EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2DQK · Special | 10/19/2018SE |
PMA approvals
- P170038 CentriMag Circulatory Support System · 12/06/2019 · 31 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0113-2026 Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F…Abbott has become aware of a limited number of tip detachment events during catheter removal from the… | 09/10/2025Open, Classified |
| Z-0112-2026 Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF…Abbott has become aware of a limited number of tip detachment events during catheter removal from the… | 09/10/2025Open, Classified |
| Z-0111-2026 Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF…Abbott has become aware of a limited number of tip detachment events during catheter removal from the… | 09/10/2025Open, Classified |
| Z-0110-2026 Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF…Abbott has become aware of a limited number of tip detachment events during catheter removal from the… | 09/10/2025Open, Classified |
| Z-0109-2026 Class I | TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D…Abbott has become aware of a limited number of tip detachment events during catheter removal from the… | 09/10/2025Open, Classified |
| Z-1644-2025 Class II | Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery… | 03/17/2025Open, Classified |
| Z-1643-2025 Class II | Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery… | 03/17/2025Open, Classified |
| Z-1480-2024 Class II | Alinity i Anti-HCV Reagent Kit, List Number 08P0521Customer complaints were received regarding falsely elevated results for some patient samples. Internal… | 03/04/2024Open, Classified |
| Z-1479-2024 Class II | ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35Customer complaints were received regarding falsely elevated results for some patient samples. Internal… | 03/04/2024Open, Classified |
| Z-0209-2024 Class II | Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generatorCertain NT2000iX RF generators were serviced using a tool that was subsequently found to be out of tolerance… | 09/28/2023Open, Classified |
| Z-2110-2023 Class I | Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous…There is an overall reported incidence rate of 0.77% related to observed or potential air embolism during… | 06/12/2023Open, Classified |
| Z-1344-2022 Class II | Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF…When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation… | 06/09/2022Open, Classified |
| Z-1213-2022 Class II | FIRMap" Catheter, 60mm BasketIncorrect product labeling. | 04/28/2022Terminated |
| Z-0957-2022 Class II | Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD…Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the… | 03/24/2022Open, Classified |
| Z-0956-2022 Class II | Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F…Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the… | 03/24/2022Open, Classified |
| Z-0420-2022 Class II | Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MMAs a result of a manufacturing error, one (1) lot of Ultimum Hemostasis Introducer devices was manufactured… | 11/16/2021Terminated |
| Z-0895-2022 Class II | Amplatzer Steerable Delivery SheathInstructions for use were updated. | 11/09/2021Terminated |
| Z-2701-2020 Class II | Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci series software…Quality Control results were not properly evaluated for QC failures. | 06/19/2020Terminated |
| Z-2541-2020 Class II | TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN…High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz… | 05/22/2020Terminated |
| Z-2401-2020 Class II | Alinity C, Processing Module. Chemistry analyzer for in-vitro diagnostics.There is a potential to generate incorrect patient results for the following assays: Alkaline Phosphatase… | 05/12/2020Terminated |
| Z-2117-2020 Class II | ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in…Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity… | 04/24/2020Open, Classified |
| Z-1728-2020 Class II | ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a… | 03/09/2020Terminated |
| Z-1700-2020 Class II | Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient…Internal testing of software identified software anomaly scenarios where if non-applicable shock energy… | 02/28/2020Terminated |
| Z-1580-2020 Class II | LN 3R70-01; software version 2.6.2 and earlier. The software is used with the Alinity i…Abbott has identified potential performance issues for the Alinity ci -series Software version 2.6.2 and… | 01/24/2020Terminated |
| Z-0574-2020 Class II | ARCHITECT HAVAB-G Calibrator, REF 6L27-01Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Relative Light… | 11/07/2019Terminated |
| Z-0575-2020 Class II | Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui Diagnostics P.E.I.…Abbott internal studies have determined that atmospheric Carbon Dioxide (CO2) can be absorbed into the… | 10/23/2019Terminated |
| Z-0545-2020 Class II | Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk SolutionPotential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of… | 09/16/2019Open, Classified |
| Z-0544-2020 Class II | Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk SolutionPotential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of… | 09/16/2019Open, Classified |
| Z-0543-2020 Class II | Alinity ci Level Sensor, Bulk SolutionPotential reliability issue with the Alinity ci series Level Sensor, Bulk Solution. The development of… | 09/16/2019Open, Classified |
| Z-2363-2019 Class II | Alinity ci -series System ControlModule, Part Number 03R70 01 Product Usage: The Alinity…Abbott has identified an issue with all on market versions (v2.6.0 and v2.6.1) of Alinity ci series Software… | 06/10/2019Terminated |
| Z-2201-2019 Class II | The Alinity ci-series System Control Modules which are configured with Alinity c…All versions of the Alinity ci-series software may not detect an issue on the Alinity c Integrated Chip… | 05/21/2019Terminated |
| Z-1709-2019 Class II | Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes…Individual cuvettes within the Alinity c Cuvette Segment may become seated lower than the designed height.… | 04/15/2019Terminated |
| Z-1497-2019 Class II | Alinity i Processing Module, 03R65 01, with the below components. a. TED (Thermo…Potential loose cable connections on the reagent cooler, which could result in temperature errors and… | 04/05/2019Terminated |
| Z-1316-2019 Class II | Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with…Potential performance issues in the Alinity-ci software version 2.5.1 | 03/07/2019Terminated |
| Z-1197-2019 Class II | Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The Alinity c processing…The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not… | 02/26/2019Terminated |
| Z-1196-2019 Class II | Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The Alinity i processing…The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not… | 02/26/2019Terminated |
| Z-0789-2019 Class II | Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Number A-30108552-01 (c)…Abbott has identified an issue with the Alinity i Gear Pump Assembly (part number A 30108552 01) resulting… | 12/20/2018Terminated |
| Z-1220-2019 Class II | St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product…The device is unable to pair with the mobile app due to the device incorrectly determining the certificate… | 11/19/2018Terminated |
| Z-1774-2018 Class I | Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT -…Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will… | 04/05/2018Terminated |
| Z-1629-2018 Class II | ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent microparticle…Falsely elevated results may be obtained when using the ARCHITECT DHEA-S assay with samples from infants up… | 12/14/2017Terminated |