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Abbott Medical FDA Recalls
39 recalls on file across devices, 7 of them Class I and 39 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 softwareClass IIMay 12, 2026Software malfunction may occur during pacing capture thresho |
| Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400Class IIOct 6, 2025There is a potential issue affecting Eterna Spinal Cord Stim |
| Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400Class IIOct 6, 2025There is a potential issue affecting Eterna Spinal Cord Stim |
| Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code: 05415067040725 REF LSP112V UDI-DI codClass IIFeb 15, 2025Due to a manufacturing issue, leadless pacemakers may have b |
| The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming Class IINov 21, 2024Due to a programmer software anomaly, during finalizing of t |
| Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, SterileClass IIOct 17, 2024A manufacturing error resulting in acceptance of valves with |
| Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm, NVRO-35, SterileClass IIOct 17, 2024A manufacturing error resulting in acceptance of valves with |
| Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, SterileClass IIOct 17, 2024A manufacturing error resulting in acceptance of valves with |
| Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29, SterileClass IIOct 17, 2024A manufacturing error resulting in acceptance of valves with |
| Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27, SterileClass IIOct 17, 2024A manufacturing error resulting in acceptance of valves with |
| Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with the MerlinOnDemand" (MoD) capaClass IIIOct 1, 2024Due to heart transmitter not being able to upgrade to the cu |
| Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to transfer stored data from the pClass IIIOct 1, 2024Due to heart transmitter not being able to upgrade to the cu |
| Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx OnlyClass IIMay 22, 2024Their is a potential that the implantable pulse generator re |
| Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx OnlyClass IIMay 22, 2024Their is a potential that the implantable pulse generator re |
| Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx OnlyClass IIMay 22, 2024Their is a potential that the implantable pulse generator re |
| Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx OnlyClass IIMay 22, 2024Their is a potential that the implantable pulse generator re |
| Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx OnlyClass IIMay 16, 2024The duration between the implantable pulse generator reachi |
| Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx OnlyClass IIMay 16, 2024The duration between the implantable pulse generator reachi |
| Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx OnlyClass IIMay 16, 2024The duration between the implantable pulse generator reachi |
| Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx OnlyClass IIMay 16, 2024The duration between the implantable pulse generator reachi |
| Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx OnlyClass IIMay 16, 2024The duration between the implantable pulse generator reachi |
| Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx OnlyClass IIMay 16, 2024The duration between the implantable pulse generator reachi |
| Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx OnlyClass IIMay 16, 2024The duration between the implantable pulse generator reachi |
| Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLYClass IIMay 16, 2024Deep brain stimulation system will first turn off after appr |
| Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx OnlyClass IIMay 16, 2024The duration between the implantable pulse generator reachi |
| Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx OnlyClass IIMay 16, 2024The duration between the implantable pulse generator reachi |
| Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx OnlyClass IIMay 16, 2024The duration between the implantable pulse generator reachi |
| Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx OnlyClass IIMay 16, 2024The duration between the implantable pulse generator reachi |
| Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx OnlyClass IIMay 16, 2024The duration between the implantable pulse generator reachi |
| Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEOClass IIFeb 5, 2024Their is a potential that electromagnetic interference may c |
| Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac ResynchronizaClass IIAug 16, 2023Due to Bluetooth malfunction on a subset of Implantable Card |
| Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter DefibrillaClass IIAug 16, 2023Due to Bluetooth malfunction on a subset of Implantable Card |
| Infinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an eleClass IJul 18, 2023Firm has received complaints from patients who are unable to |
| Proclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an eClass IJul 18, 2023Firm has received complaints from patients who are unable to |
| Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an eleClass IJul 18, 2023Firm has received complaints from patients who are unable to |
| Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is aClass IJul 18, 2023Firm has received complaints from patients who are unable to |
| Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description:Class IJul 18, 2023Firm has received complaints from patients who are unable to |
| Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Class IJul 18, 2023Firm has received complaints from patients who are unable to |
| Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is aClass IJul 18, 2023Firm has received complaints from patients who are unable to |