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Browse Device Recalls

56 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 56 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 56 FDA device recalls.

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DateProductReasonClassFirm
Jun 14, 2023 Impella LD intravascular micro axial blood pump, Product Number 005082 There is a potential risk for unintentional interaction of the Impella motor housing with the dis... Class I Abiomed, Inc.
May 26, 2023 Abiomed 14Fr Low Profile Introducer Set, Product Number 1000457 There was one complaint that the sidearm of the device detached during explant of a pump. When t... Class II Abiomed, Inc.
Apr 17, 2023 Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood p... The Impella 5.5 pump experienced a heightened complaint rate for purge leaks. Class I Abiomed, Inc.
Dec 14, 2021 OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. ... The firm has received complaints of the OXY-1 System Console experiencing a power interruption wh... Class I Abiomed, Inc.
Mar 1, 2021 Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0... Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software U... Class II Abiomed, Inc.
Sep 4, 2019 lmpella CP with Smart Assist, Model Number: 0048-0003. Left heart support b... This one pump shipped with incorrect pump programming, the initial production working version of ... Class II Abiomed, Inc.

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.