The Recall Desk

Manufacturer

Abbott Medical

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

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.

1–25 of 39

  • HighFDA (Devices)·Z-2405-2026·2026-06-17

    Abbott Merlin pacemaker programmer may fail to terminate threshold test

    Merlin Patient Care System programmer software is being recalled because a malfunction during a pacing capture threshold test may stop the command to terminate the test being communicated.

    Product
    Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0459-2026·2025-11-19

    Deep brain stimulators recalled over loss of programmer communication

    Abbott Medical is recalling 722 Liberta RC deep brain stimulation implantable pulse generators because the devices may lose communication with the clinician programmer or patient controller.

    Product
    Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0458-2026·2025-11-19

    Spinal cord stimulators recalled over loss of programmer communication

    Abbott Medical is recalling 20,715 Eterna spinal cord stimulation implantable pulse generators because the devices may lose communication with the clinician programmer or patient controller.

    Product
    Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1557-2025·2025-04-23

    Abbott Aveir DR Leadless Pacemaker Recalled for Battery Failure Risk

    Abbott Medical is recalling specific Aveir DR Leadless Pacemaker devices due to manufacturing exposure to higher-than-normal temperatures that may cause premature battery failure.

    Product
    Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Aveir leadless pacemaker system supports the implantation and use of an Aveir Leadless Pacemaker (LP) within the targeted chamber(s) of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0753-2025·2025-01-01

    Merlin PCS 3650 Pacemaker Programmer Software Anomaly May Cause Loss of Pacing

    A software anomaly in Abbott's Merlin PCS 3650 programmer may prevent proper finalization of leadless pacemakers, causing loss of pacing function. The issue occurs when specific actions combine with brief telemetry loss.

    Product
    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0552-2025·2024-12-04

    Heart Device Transmitter Fails to Update Software After Power Interruption

    Abbott Medical's Merlin@home transmitter cannot upgrade to current software after power interruptions during prior downloads. This affects remote heart device monitoring systems.

    Product
    Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitter configured for multiple patient use. It can receive information from an implantable heart device in unpaired mode. With MoD capability
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0551-2025·2024-12-04

    Abbott Merlin@home Cardiac Monitoring Transmitters Fail to Update After Power Loss

    Abbott is recalling 130 Merlin@home cardiac transmitters that cannot update software after power interruption during firmware download. Affected devices remain on outdated firmware with no ability to receive future updates.

    Product
    Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted heart device to Merlin.net" Patient Care Network (PCN) to facilitate remote monitoring by using inductive (EX1100 Model) or RF telemetry (E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0493-2025·2024-11-27

    Abbott Navitor Transcatheter Aortic Heart Valve Recalled for Manufacturing Defect

    Three Abbott Navitor 29mm transcatheter aortic heart valves were recalled due to a manufacturing error that allowed valves with leaflet deflection outside specifications to be distributed. The defect could affect valve durability or cause valve failure.

    Product
    Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0492-2025·2024-11-27

    Abbott Navitor Transcatheter Aortic Heart Valve Recalled for Manufacturing Defect

    Abbott Medical is recalling the Navitor 29mm transcatheter aortic heart valve due to a manufacturing error affecting leaflet specifications. The defect could potentially impact long-term valve durability or cause valve failure.

    Product
    Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0495-2025·2024-11-27

    Abbott Navitor Transcatheter Aortic Valve Recalled for Manufacturing Defect

    Abbott is recalling Abbott Navitor Transcatheter Aortic Heart Valves (27 mm) due to a manufacturing error causing leaflet deflection values outside specifications. This could affect valve durability and potentially cause valve failure.

    Product
    Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0491-2025·2024-11-27

    Abbott Navitor Titan Heart Valve Recall: Manufacturing Defect

    Abbott Medical is recalling 10 units of the Abbott Navitor Titan transcatheter aortic heart valve due to a manufacturing error causing valve leaflets to fall outside specification. The defect could affect valve durability and cause valve failure.

    Product
    Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0494-2025·2024-11-27

    Abbott Navitor Heart Valve Recalled for Leaflet Deflection Manufacturing Defect

    Abbott Medical is recalling 8 units of the Navitor 27mm transcatheter aortic heart valve due to a manufacturing error in leaflet deflection that may affect valve durability and function.

    Product
    Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2430-2024·2024-07-31

    Abbott Infinity 5 Pulse Generator May Fail Prematurely

    Abbott is recalling 5,900 Infinity 5 implantable pulse generators because the replacement indicator and end-of-service date may be shorter than labeled, potentially causing premature device failure. Patients should contact their doctor about device status.

    Product
    Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2431-2024·2024-07-31

    Abbott Infinity 7 Pulse Generator May Have Shorter-Than-Labeled Service Date

    The Abbott Infinity 7 implantable pulse generator's replacement indicator and end-of-service date may be shorter than the product labeling states, potentially leading to loss of therapy for patients.

    Product
    Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2429-2024·2024-07-31

    Abbott Infinity 5 Pulse Generator May Have Inaccurate Battery-Life Labels

    Abbott Infinity 5 implantable pulse generators have inaccurate end-of-service dates in labeling, which may result in loss of therapy. Approximately 5,900 units are affected and distributed worldwide.

    Product
    Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2432-2024·2024-07-31

    Abbott Infinity 7 Implantable Pulse Generators Recalled for Potentially Shortened Service Life

    Abbott is recalling 1198 Infinity 7 Implantable Pulse Generators due to potentially incorrect service life indicators and end-of-service dates in product labeling, which could result in loss of therapy.

    Product
    Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2360-2024·2024-07-24

    Abbott Proclaim XR 7 Implantable Pulse Generator Service Life Shorter Than Labeled

    Abbott Proclaim XR 7 implantable pulse generators may have a shorter service life than indicated in product labeling. Approximately 9,006 units distributed worldwide are affected.

    Product
    Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2361-2024·2024-07-24

    Abbott Proclaim 7 Implantable Pulse Generator May Reach End-of-Service Sooner Than Labeled

    Abbott is recalling 569 units of the Proclaim 7 implantable pulse generator because the device may reach end-of-service sooner than indicated in labeling. All affected units were distributed worldwide.

    Product
    Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2363-2024·2024-07-24

    Abbott Proclaim 7 Pulse Generator Battery Life Shorter Than Labeled

    Abbott is recalling approximately 457 Proclaim 7 Implantable Pulse Generators because the battery may reach end of service sooner than indicated in labeling. Patients may require unexpected device replacement.

    Product
    Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2364-2024·2024-07-24

    Abbott Proclaim Plus 5 Pulse Generator Battery Life Shorter Than Labeled

    Abbott is recalling 8,401 units of the Proclaim Plus 5 Implantable Pulse Generator because the battery may reach end-of-service sooner than the product labeling indicates.

    Product
    Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2367-2024·2024-07-24

    Abbott Proclaim DRG implantable pulse generator service life shorter than labeled

    Abbott is recalling 21,843 Proclaim DRG implantable pulse generators because the duration between the device's elective replacement indicator and end of service may be shorter than stated in product labeling.

    Product
    Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2368-2024·2024-07-24

    Abbott Recalls Proclaim 7 Elite Pulse Generator for Battery Life Discrepancy

    Abbott Medical is recalling Proclaim 7 Elite Implantable Pulse Generators because the device may reach end of service sooner than indicated in the product labeling. Patients should consult their healthcare provider.

    Product
    Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2366-2024·2024-07-24

    Abbott Proclaim Plus 7 implantable pulse generator recalled for shortened service life

    Abbott recalls 1,086 Proclaim Plus 7 implantable pulse generators due to labeling inaccuracy. Devices may reach end of service sooner than labeled, potentially reducing the time patients have to plan for replacement.

    Product
    Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2365-2024·2024-07-24

    Abbott Proclaim Plus 5 Pulse Generator May Have Shorter Service Life Than Labeled

    Abbott is recalling 38 Proclaim Plus 5 Implantable Pulse Generators because they may reach end of service sooner than product labeling indicates, potentially affecting pain management therapy for affected patients.

    Product
    Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide