FDA recall record · openFDA
Abbott Medical
39 FDA recalls on record (2023–2026) — 39 device. 39 still ongoing.
7
Class I (most serious)
30
Class II
2
Class III
39
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of s 12
Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (I 7
A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was outside of established 5
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter t 4
Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Th 2
Recalls
Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is a Class I 2023-07-18 Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Class I 2023-07-18 Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an ele Class I 2023-07-18 Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an ele Class I 2023-07-18 Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: Class I 2023-07-18 Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an e Class I 2023-07-18 Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is a Class I 2023-07-18 Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 software Class II 2026-05-12 Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 Class II 2025-10-06 Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 Class II 2025-10-06 Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI cod Class II 2025-02-15 Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only Class II 2024-05-16 Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only Class II 2024-05-22 Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only Class II 2024-05-16 Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only Class II 2024-05-22 Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile Class II 2024-10-17 Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile Class II 2024-10-17 Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only Class II 2024-05-16 Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only Class II 2024-05-16 Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Only Class II 2024-05-16 The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming Class II 2024-11-21 Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, Sterile Class II 2024-10-17 Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only Class II 2024-05-16 Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, Sterile Class II 2024-10-17 Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY Class II 2024-05-16 Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only Class II 2024-05-16 Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only Class II 2024-05-16 Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only Class II 2024-05-22 Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only Class II 2024-05-16 Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only Class II 2024-05-16 Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only Class II 2024-05-16 Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, Sterile Class II 2024-10-17 Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only Class II 2024-05-22 Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only Class II 2024-05-16 Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEO Class II 2024-02-05 Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrilla Class II 2023-08-16 Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchroniza Class II 2023-08-16 Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the p Class III 2024-10-01 Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capa Class III 2024-10-01
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.