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Abbott Medical Recalls
43 recalls on record · December 18, 2019 to June 17, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 17, 2026Medical DevicesFDA
Abbott Medical recalls Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
Hazard: Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
November 19, 2025Medical DevicesFDA
Abbott Medical recalls Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
Hazard: There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).
November 19, 2025Medical DevicesFDA
Abbott Medical recalls Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Hazard: There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).
April 23, 2025Medical DevicesFDA
Abbott Medical recalls Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI cod
Hazard: Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure.
January 1, 2025Medical DevicesFDA
Abbott Medical recalls The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming
Hazard: Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the finalization step to fail. If this occurs, the Programmer displays a loss of telemetry detected window, and there is no pacing.
December 4, 2024Medical DevicesFDA
Abbott Medical recalls Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capa
Hazard: Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
December 4, 2024Medical DevicesFDA
Abbott Medical recalls Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the p
Hazard: Due to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a prior over-the-wire software download.
November 27, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
Hazard: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
November 27, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
Hazard: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
November 27, 2024Medical DevicesFDA
Abbott Medical recalls Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
Hazard: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
November 27, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
Hazard: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
November 27, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
Hazard: A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established specifications. This could potentially affect long-term durability of the impacted valve and/or cause potential valve failure.
July 31, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
Hazard: Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
July 31, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only
Hazard: Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
July 31, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only
Hazard: Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
July 31, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
Hazard: Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 10, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Hazard: Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy.
May 8, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
Hazard: Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.