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Browse Device Recalls

14 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 14 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 14 FDA device recalls.

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DateProductReasonClassFirm
Sep 20, 2018 Cardiosave Rescue IABP, Part Number 0998-UC-0800-83 There is a potential for interruption and/or inability to start therapy to the patient prior to o... Class I Maquet Datascope Corp - Cardiac Assist Division
Sep 20, 2018 Cardiosave Hybrid IABP, Part Number 0998-00-0800-53 There is a potential for interruption and/or inability to start therapy to the patient prior to o... Class I Maquet Datascope Corp - Cardiac Assist Division
May 3, 2018 CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-... Ingress of fluids into the device can affect various electronic circuit boards which would preven... Class I Maquet Datascope Corp - Cardiac Assist Division
Jul 17, 2017 CS 300 Intra-Aortic Balloon Pump. It supports the heart's left ventricle b... False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... Class I Maquet Datascope Corp - Cardiac Assist Division
Jul 17, 2017 CS 100i Intra-Aortic Balloon Pump. It supports the heart's left ventricle ... False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... Class I Maquet Datascope Corp - Cardiac Assist Division
Jul 17, 2017 CS 100 Intra-Aortic Balloon Pump. It supports the heart's left ventricle b... False blood back detection alarm and the ingress of fluids into the IABP affecting various electr... Class I Maquet Datascope Corp - Cardiac Assist Division
Jun 16, 2017 CS 100 Intra-Aortic Balloon Pump The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m... Class I Maquet Datascope Corp - Cardiac Assist Division
Jun 16, 2017 CS 100i Intra-Aortic Balloon Pump The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m... Class I Maquet Datascope Corp - Cardiac Assist Division
Jun 16, 2017 CS 300 Intra-Aortic Balloon Pump The device failed to pump due to an electrical test failure code #58 (power up vent test fail), m... Class I Maquet Datascope Corp - Cardiac Assist Division
Dec 23, 2016 CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 09... Maquet has received 3 confirmed complaints related to the Li-lon Battery used with the Maquet CAR... Class II Maquet Datascope Corp - Cardiac Assist Division
Dec 16, 2015 Cardiosave Hybrid and rescue IABP Maquet has recieved information that in some Cardiosave IABPS, the scroll compressor did not meet... Class II Maquet Datascope Corp - Cardiac Assist Division
Jan 30, 2015 Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) Power supply malfunction complaints related to suboptimal thermal management. Class II Maquet Datascope Corp - Cardiac Assist Division
Dec 16, 2014 CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and... Ferrule Cap was not removed on some fiber-optic Sensation and Sensation Plus IABC demonstration u... Class II Maquet Datascope Corp - Cardiac Assist Division
Mar 21, 2014 Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump.... Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly... Class I Maquet Datascope Corp - Cardiac Assist Division

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.