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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
Apr 29, 2015 HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Produ... Failures of the splice repair kit if exposed to excessive force. Class I HeartWare Inc
Apr 29, 2015 HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac tr... Complaints with the HVAD Abnormal Power Source Switching. Class II HeartWare Inc
Apr 29, 2015 HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 ... Complaints with the HVAD Internal Controller Alarm Battery failures. Class I HeartWare Inc
Apr 29, 2015 HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / ... HeartWare has received complaints relating to damage or bent connection pins within the power sup... Class I HeartWare Inc
Apr 29, 2015 HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 110... Complaints with the HVAD Retraction of Pins within the driveline connector. Class I HeartWare Inc
Apr 29, 2015 HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac tra... Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath. Class II HeartWare Inc
Jan 16, 2015 HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: ... The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commerc... Class I HeartWare Inc
Apr 16, 2014 HeartWare HVAD Pump Implant Kit (Heartware Ventricular Assist Device) - Heart... Patients and caregivers are instructed that if a battery does not provide two hours of support or... Class II HeartWare Inc
Dec 6, 2013 Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catal... The housing to the Pump's driveline connector became partially or fully separated from the front ... Class I HeartWare Inc
May 16, 2013 Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Potential to electrostatic discharged (ESD) Class II HeartWare Inc
Dec 27, 2012 Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosen... Class II Heartware 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.