Abbott Recalls
21 recalls on record · May 23, 2018 to October 22, 2025 · Medical Devices
Recalls by year
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22
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25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 22, 2025Medical DevicesFDA
Abbott recalls TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
Hazard: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
October 22, 2025Medical DevicesFDA
Abbott recalls TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Hazard: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
October 22, 2025Medical DevicesFDA
Abbott recalls TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
Hazard: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
October 22, 2025Medical DevicesFDA
Abbott recalls TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
Hazard: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
October 22, 2025Medical DevicesFDA
Abbott recalls TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
Hazard: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
April 30, 2025Medical DevicesFDA
Abbott recalls Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Hazard: 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 prolonged procedure, blood loss, or air ingress with potential for air embolism.
April 30, 2025Medical DevicesFDA
Abbott recalls Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
Hazard: 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 prolonged procedure, blood loss, or air ingress with potential for air embolism.
April 10, 2024Medical DevicesFDA
Abbott GmbH recalls Alinity i Anti-HCV Reagent Kit, List Number 08P0521
Hazard: Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).
April 10, 2024Medical DevicesFDA
Abbott GmbH recalls ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35
Hazard: Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).
November 8, 2023Medical DevicesFDA
Abbott recalls Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
Hazard: 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 results for potential capacitance failure.
July 19, 2023Medical DevicesFDA
Abbott recalls Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
Hazard: 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.
July 13, 2022Medical DevicesFDA
Abbott recalls Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart
Hazard: When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter."
June 8, 2022Medical DevicesFDA
Abbott recalls FIRMap" Catheter, 60mm Basket
Hazard: Incorrect product labeling.
April 27, 2022Medical DevicesFDA
Abbott recalls Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
Hazard: Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
April 27, 2022Medical DevicesFDA
Abbott recalls Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
Hazard: Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.
April 13, 2022Medical DevicesFDA
Abbott recalls Amplatzer Steerable Delivery Sheath
Hazard: Instructions for use were updated.
January 5, 2022Medical DevicesFDA
Abbott recalls Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
Hazard: 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 devices manufactured were 12 cm in length instead of the intended 5 cm in length.
July 15, 2020Medical DevicesFDA
Abbott recalls TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN
Hazard: High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter
April 22, 2020Medical DevicesFDA
Abbott recalls Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model
Hazard: Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained.
May 1, 2019Medical DevicesFDA
Abbott recalls St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Con
Hazard: The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
May 23, 2018Medical DevicesFDA
Abbott recalls Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for p
Hazard: Reports of outflow graft twist occlusions. Patients whose devices experience outflow graft occlusions will experience a persistent low flow alarm. Outflow graft occlusions can result in serious adverse events such as hemodynamic compromise, thrombus, and death.