The Recall Desk

Manufacturer

Abbott

19 recalls in our database name Abbott as the manufacturing or recalling firm.

What the numbers show

Total
19
Critical
6
Severe
4
Most recent
2025-10-22

Of the 19 recalls from Abbott we have scored against our rubric, 6 (32%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 4 (21%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–19 of 19

  • CriticalFDA (Devices)·Z-0109-2026·2025-10-22

    UniD curve ablation catheters recalled after tip detachment from packaging

    Abbott is recalling 407 TactiFlex Sensor Enabled Ablation Catheters in the UniD curve D configuration after becoming aware of tip detachment events during removal from the packaging.

    Product
    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0111-2026·2025-10-22

    Curve D-F ablation catheters recalled after tip detachment from packaging

    Abbott is recalling 85,803 TactiFlex Sensor Enabled Ablation Catheters in the D-F curve after becoming aware of tip detachment events during removal from the packaging.

    Product
    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0112-2026·2025-10-22

    Curve F-J ablation catheters recalled after tip detachment during unpacking

    Abbott is recalling 11,810 TactiFlex Sensor Enabled Ablation Catheters in the F-J curve after becoming aware of tip detachment events during removal from the packaging.

    Product
    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0113-2026·2025-10-22

    UniD curve F ablation catheters recalled after tip detachment from packaging

    Abbott is recalling 1,960 TactiFlex Sensor Enabled Ablation Catheters in the UniD curve F configuration after becoming aware of tip detachment events during removal from the packaging.

    Product
    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0110-2026·2025-10-22

    Curve D-D ablation catheters recalled after tip detachment from packaging

    Abbott is recalling 3,404 TactiFlex Sensor Enabled Ablation Catheters in the D-D curve after becoming aware of tip detachment events during removal from the packaging.

    Product
    TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1643-2025·2025-04-30

    Amplatzer TorqVue LP Delivery System Recall for Shaft Breach

    Abbott is recalling specific lots of the Amplatzer TorqVue LP Delivery System due to a possible small breach in the shaft that is not visible but could lead to prolonged procedures, blood loss, or air embolism.

    Product
    Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1644-2025·2025-04-30

    Amplatzer TorqVue LP Catheter Recalled for Shaft Breach Risk

    Abbott is recalling the Amplatzer TorqVue LP Catheter (Model 9-TVLPC4F90/080) due to a potential small breach in the proximal shaft that may not be visible and could lead to prolonged procedures, blood loss, or air embolism.

    Product
    Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0209-2024·2023-11-08

    Abbott NT2000iX radiofrequency generator serviced with out-of-tolerance tool

    Abbott is recalling 34 NT2000iX radiofrequency generators that were serviced using an out-of-tolerance calibration tool, which may have provided inaccurate measurement results for capacitance failures.

    Product
    Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesioning generator
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2110-2023·2023-07-19

    Abbott Cardiac Catheter Sheath Recalled Due to Air Embolism Risk

    Abbott is recalling the Amplatzer Steerable Delivery Sheath (ASDS), a cardiac catheter, due to a 0.77% reported incidence rate of air embolism during procedures. The recalled 675 units are distributed worldwide.

    Product
    Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, is a percutaneous catheter (cardiac).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1344-2022·2022-07-13

    Abbott TactiCath Ablation Catheter System Error Display Malfunction

    Abbott recalls 191 TactiCath cardiac ablation catheters that may display incorrect error messages when connected to the EnSite Precision Navigation System, potentially causing user confusion.

    Product
    Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1213-2022·2022-06-08

    Abbott FIRMap Catheter Recalled for Incorrect Product Labeling

    Abbott is recalling 40 units of FIRMap® Catheter, 60mm Basket due to incorrect product labeling. The recall affects devices distributed in Missouri, California, Ohio, Washington and internationally in Italy and Netherlands.

    Product
    FIRMap" Catheter, 60mm Basket
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0957-2022·2022-04-27

    Abbott TactiCath Ablation Catheters Recalled for Software-Disabled Devices

    Abbott has recalled 588 TactiCath ablation catheters that were preprogrammed with a 'First Use Date' disabling device functionality. The catheters were distributed worldwide and throughout the U.S.

    Product
    Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0956-2022·2022-04-27

    Abbott TactiCath Ablation Catheter Disabled by Preprogrammed First-Use Date

    Abbott is recalling 2,134 TactiCath ablation catheters manufactured with a preprogrammed 'First Use Date' that disables the device. Affected devices with 37 specific lot numbers were distributed in the U.S. and 21 other countries.

    Product
    Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0895-2022·2022-04-13

    Abbott Amplatzer Steerable Delivery Sheath instructions for use updated

    Abbott is recalling 529 units of the Amplatzer Steerable Delivery Sheath (Class II) distributed outside the US due to an update to the device's instructions for use.

    Product
    Amplatzer Steerable Delivery Sheath
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0420-2022·2022-01-05

    Ultimum Hemostasis Introducer devices recalled due to manufacturing error

    Abbott is recalling one lot of Ultimum Hemostasis Introducer devices due to a manufacturing error that resulted in incorrect hub and length. Affected devices are 12 cm long instead of the intended 5 cm.

    Product
    Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2541-2020·2020-07-15

    Abbott Recalls TactiCath Quartz Contact Force Ablation Catheters Due to Data Loss

    Abbott is recalling TactiCath Quartz Contact Force Ablation Catheters because they may lose contact force information during use.

    Product
    TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart and,
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1700-2020·2020-04-22

    Abbott Recalls Merlin PCS 3650 Software Upgrade Kit Due to Anomaly

    Abbott is recalling the Merlin PCS 3650 Software Upgrade Kit because a software anomaly may cause the device to use a previously programmed shock energy level without alerting the user.

    Product
    Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-1220-2019·2019-05-01

    Abbott Recalls 32 St. Jude Medical Confirm Rx Insertable Cardiac Monitors

    Abbott is recalling 32 St. Jude Medical Confirm Rx Insertable Cardiac Monitors because the devices incorrectly determine that their security certificates have expired, preventing them from pairing with the mobile app.

    Product
    St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1774-2018·2018-05-23

    Abbott HeartMate 3 LVAS Implant Kit Recalled for Graft Occlusion Risk

    Abbott is recalling HeartMate 3 LVAS Implant Kits due to reports of outflow graft twist occlusions that can cause serious adverse events.

    Product
    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.
    Category
    Medical Device
    Distribution
    35 states