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Browse Device Recalls

12 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 12 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 12 FDA device recalls.

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DateProductReasonClassFirm
May 8, 2024 Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US,... System monitor screen may display atypical behavior: Overlapping screens/buttons, Frozen screen, ... Class I Thoratec Corp.
Mar 1, 2024 Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly Potential for a leak path at the seal interface between the left ventricle assist system inflow c... Class I Thoratec Corp.
Mar 1, 2024 Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly Potential for a leak path at the seal interface between the left ventricle assist system inflow c... Class I Thoratec Corp.
Feb 19, 2024 HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Out... Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated... Class I Thoratec Corp.
Feb 19, 2024 HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed O... Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated... Class I Thoratec Corp.
Jan 3, 2024 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Comm... Due to software and controller systems that results in unexpected pump start or pump stop. Class I Thoratec Corp.
Aug 7, 2023 Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & Heart... Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical... Class II Thoratec Corp.
Oct 22, 2021 Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Re... If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-en... Class II Thoratec Corp.
Dec 2, 2019 HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 1... Excessive static electricity can potentially cause unrecoverable power loss and damage to the mob... Class II Thoratec Corp.
Mar 30, 2019 Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only,... Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is in... Class II Thoratec Corp.
Mar 30, 2019 Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 1055... Outflow Graft leaking at the pump connection during the implantation process. If the C-Ring is in... Class II Thoratec Corp.
Mar 1, 2019 Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an opti... Small black plastic particle was observed in the left ventricle during implant procedure. Class II Thoratec Corp.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.