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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Sep 14, 2017 Peripheral Diamondback 1.25 Solid OAD, a percutaneous orbital atherectomy sys... Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the la... Class II Cardiovascular Systems Inc
Sep 14, 2017 Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy sys... Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the la... Class II Cardiovascular Systems Inc
Apr 14, 2017 CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Nu... Cardiovascular Systems, Inc. (CSI). has initiated a recall to remove 1,396 7-10014 Saline Infusi... Class II Cardiovascular Systems Inc
Mar 3, 2017 ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18.... Cardiovascular Systems, Inc. is recalling one lot of ViperWire Advance with Flextip, model VPR-GW... Class II Cardiovascular Systems Inc
Mar 4, 2015 Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. ... The OAD saline sheath outer layer may flake off from the catheter due to friction between the out... Class I Cardiovascular Systems, Inc.
May 23, 2014 CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherect... CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because i... Class I Cardiovascular Systems, Inc.
Jan 27, 2014 CSI, Diamondback 360 Coronary Orbital Atherectomy System, Part Number 70058-0... Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return o... Class III Cardiovascular Systems, Inc.
Jun 18, 2012 CSI Stealth 360-degree Orbital Atherectomy Device (OAD), Part Number 70056-11... CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devi... Class II Cardiovascular Systems, 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.