Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Device Recalls

78 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 78 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 78 FDA device recalls.

Clear
DateProductReasonClassFirm
Feb 26, 2021 Instructions for Use and Patient Manual for HeartWare HVAD System. Accompani... IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling ... Class II Heartware, Inc.
Nov 19, 2020 Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, ... Pumps manufactured with impellers from a subset of lots from a single supplier are failing to ini... Class I Heartware, Inc.
Apr 3, 2020 Heartware HVAD Pump Implant accessories, Product (REF) Number 1153 The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... Class I Heartware, Inc.
Apr 3, 2020 Heartware HVAD Pump Implant Kit, Product (REF) Number 1104JP The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... Class I Heartware, Inc.
Apr 3, 2020 Heartware HVAD Pump Implant Kit, Product (REF) Number 1104 The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... Class I Heartware, Inc.
Apr 3, 2020 Heartware HVAD Pump Outflow Graft, Product (REF) Number 1125 The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... Class I Heartware, Inc.
Apr 3, 2020 Heartware HVAD Pump Implant Kit, Product (REF) Number 1103 The Outflow Graft may be subject to tears and the Strain Relief screw may break during the pre-im... Class I Heartware, Inc.
Jan 23, 2020 HeartWare HVAD System Battery Charger The HeartWare HVAD System is indica... Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVA... Class I Heartware, Inc.
Jan 23, 2020 HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD System... Potential for an HVAD System user to mistakenly insert the Battery Charger AC Adapter into an HVA... Class I Heartware, Inc.
Nov 19, 2018 Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600... HVAD Battery Charger units manufactured with wrong inductors. Class II Heartware, Inc.
Aug 28, 2018 Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 14... Certain HVAD System Controller units may not meet the labeled standard for protection against wat... Class II Heartware, Inc.
May 2, 2018 Heartware Medtronic HVAD System for cardiac use. Including the following pa... Possible transient electrical connection interruption between an HVAD System power source (Batter... Class I Heartware
Mar 10, 2017 HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Prod... In April 2015, HeartWare, now a part of Medtronic, notified users of a safety issue related to th... Class I Heartware
Feb 3, 2017 HeartWare HVAD System Controller The HeartWare Ventricular Assist System (V... Product recall of all HVAD Controllers currently on the market and to exchange them for the next... Class I Heartware
Aug 17, 2016 HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and... Foreign material found within the driveline connector of the HVAD Pump that could cause increased... Class I HeartWare, Inc
Jun 8, 2016 HeartWare Ventricular Assist System Controller Product Usage: For use as... Loose connector ports in controller body. Class I Heartware, Inc.
Jan 7, 2016 HeartWare Ventricular Assist System: HeartWare Battery, Lithium Ion, 14.8 V, ... Heartware Ventricular Assist System Battery Cell experiencing premature depletion. Class I Heartware, Inc.
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.