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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.

Clear
DateProductReasonClassFirm
Nov 22, 2021 WIRION EMBOLIC PROTECTION SYSTEM, Delivery Catheter and Filter and Retrieval ... Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under s... Class I Cardiovascular Systems Inc
Jul 21, 2021 STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM,... There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged ... Class II Cardiovascular Systems Inc
Jul 21, 2021 DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 ... There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged ... Class II Cardiovascular Systems Inc
Apr 13, 2018 CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Nu... The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing tr... Class II Cardiovascular Systems Inc
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
Feb 9, 2017 ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number... CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . ... Class II Cardiovascular Systems Inc
Dec 7, 2016 DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 Peripheral Or... CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED. Class II Cardiovascular Systems Inc
Jun 13, 2016 ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx O... The pouch label was missing the use by date (UBD) of 2018-04. 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.