Abbott Medical recalls
Abbott Medical appears in 43 official U.S. recall notices indexed by RecallRadar, most recently on 2026-06-17.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 43 |
|---|---|
| Published | 2019-12-18 to 2026-06-17 |
| By agency | FDA Device (43) |
| By classification | Class II (34), Class I (7), Class III (2) |
| By status | ongoing (39), terminated (4) |
| Distribution named in notices | NY, US |
Recalls
- Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software
FDA Device · Class II · 2026-06-17 · Abbott Medical
Reason: Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test. - Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
FDA Device · Class II · 2025-11-19 · Abbott Medical
Reason: 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 . T… - Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
FDA Device · Class II · 2025-11-19 · Abbott Medical
Reason: 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 . T… - Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI code: 05415067034472 The Ave…
FDA Device · Class II · 2025-04-23 · Abbott Medical
Reason: Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal temperatures which may result in premature battery failure. - The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates u…
FDA Device · Class II · 2025-01-01 · Abbott Medical
Reason: 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 fina… - Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capability is a transmitte…
FDA Device · Class III · 2024-12-04 · Abbott Medical
Reason: 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. - Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the patient s implanted hear…
FDA Device · Class III · 2024-12-04 · Abbott Medical
Reason: 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. - Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile
FDA Device · Class II · 2024-11-27 · Abbott Medical
Reason: 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 cau… - Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile
FDA Device · Class II · 2024-11-27 · Abbott Medical
Reason: 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 cau… - Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile
FDA Device · Class II · 2024-11-27 · Abbott Medical
Reason: 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 cau… - Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile
FDA Device · Class II · 2024-11-27 · Abbott Medical
Reason: 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 cau… - Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile
FDA Device · Class II · 2024-11-27 · Abbott Medical
Reason: 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 cau… - Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only
FDA Device · Class II · 2024-07-31 · Abbott Medical
Reason: 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. - Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
FDA Device · Class II · 2024-07-31 · Abbott Medical
Reason: 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. - Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
FDA Device · Class II · 2024-07-31 · Abbott Medical
Reason: 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. - Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only
FDA Device · Class II · 2024-07-31 · Abbott Medical
Reason: 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. - Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
FDA Device · Class II · 2024-07-24 · Abbott Medical
Reason: 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. - Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only
FDA Device · Class II · 2024-07-24 · Abbott Medical
Reason: 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. - Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
FDA Device · Class II · 2024-07-24 · Abbott Medical
Reason: 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. - Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
FDA Device · Class II · 2024-07-24 · Abbott Medical
Reason: 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. - Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
FDA Device · Class II · 2024-07-24 · Abbott Medical
Reason: 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. - Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Only
FDA Device · Class II · 2024-07-24 · Abbott Medical
Reason: 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. - Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only
FDA Device · Class II · 2024-07-24 · Abbott Medical
Reason: 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. - Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only
FDA Device · Class II · 2024-07-24 · Abbott Medical
Reason: 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. - Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only
FDA Device · Class II · 2024-07-24 · Abbott Medical
Reason: 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. - Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only
FDA Device · Class II · 2024-07-24 · Abbott Medical
Reason: 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. - Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only
FDA Device · Class II · 2024-07-24 · Abbott Medical
Reason: 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. - Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only
FDA Device · Class II · 2024-07-24 · Abbott Medical
Reason: 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. - Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
FDA Device · Class II · 2024-07-10 · Abbott Medical
Reason: 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 s… - Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO
FDA Device · Class II · 2024-05-08 · Abbott Medical
Reason: Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change. - Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchronization Therapy Defibrilla…
FDA Device · Class II · 2023-09-27 · Abbott Medical
Reason: Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of cryst… - Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA…
FDA Device · Class II · 2023-09-27 · Abbott Medical
Reason: Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of cryst… - Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse…
FDA Device · Class I · 2023-09-20 · Abbott Medical
Reason: Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). - Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device des…
FDA Device · Class I · 2023-09-20 · Abbott Medical
Reason: Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). - Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implant…
FDA Device · Class I · 2023-09-20 · Abbott Medical
Reason: Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). - Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed…
FDA Device · Class I · 2023-09-20 · Abbott Medical
Reason: Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). - Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed…
FDA Device · Class I · 2023-09-20 · Abbott Medical
Reason: Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). - Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device des…
FDA Device · Class I · 2023-09-20 · Abbott Medical
Reason: Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). - Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device design…
FDA Device · Class I · 2023-09-20 · Abbott Medical
Reason: Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). - Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
FDA Device · Class II · 2020-01-15 · Abbott Medical
Reason: Fast-Cath Trio Hemostasis Introducer devices contained 12F sized dilators and sheaths instead of the expected 14F devices. - Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are…
FDA Device · Class II · 2020-01-15 · Abbott Medical
Reason: Three lots of Fast-Cath Hemostasis Introducer devices contained 8F sized dilators and sheaths instead of the expected 8.5F devices. - CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electrode, REF C-1005-S - Product Usage: Disposable Radiofrequency Cannulae…
FDA Device · Class II · 2020-01-01 · Abbott Medical
Reason: A manufacturing error caused a single lot of 10mm active tip length Cannulas to be labeled as 5mm active tip length cannulas. - Radiofrequency Grounding Pad, REF RF-DGP-L
FDA Device · Class II · 2019-12-18 · Abbott Medical
Reason: Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on the grounding pad which may interfere w…