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Browse Device Recalls

19 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 19 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 19 FDA device recalls.

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DateProductReasonClassFirm
Mar 23, 2022 Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO... Packaging for Balloon Catheters may be damaged resulting in loss of sterility. Class II Medtronic Vascular, Inc.
Mar 23, 2022 Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV0600800... Packaging for Balloon Catheters may be damaged resulting in loss of sterility. Class II Medtronic Vascular, Inc.
Dec 21, 2021 Endurant, Endurant II and Endurant IIs Stent Graft System: Medtronic Endur... Stent Graft Systems built with specific batches of taper tip assemblies have the potential for th... Class II Medtronic Vascular, Inc.
Oct 15, 2021 Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT E... Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle ... Class II Medtronic Vascular, Inc.
Oct 15, 2021 Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF... During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube Class II Medtronic Vascular, Inc.
Oct 15, 2021 Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ET... Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle ... Class II Medtronic Vascular, Inc.
Jun 7, 2021 Medtronic Endurant IIs Stent Graft System Medtronic Endurant IIs Stent Gra... During product complaint investigation, it was determined that during stent graft deployment, the... Class II Medtronic Vascular, Inc.
Jun 7, 2021 Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent G... During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of th... Class II Medtronic Vascular, Inc.
Apr 28, 2021 Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. ... Incorrect stentstop assembly (18fr) was used to build the delivery system component of the device... Class II Medtronic Vascular, Inc.
Feb 12, 2021 Valiant Navion Thoracic Stent Graft System. For endovascular repair of lesio... Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement. Class I Medtronic Vascular, Inc.
Sep 13, 2017 Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF H... It was determined that the deflection length indicated on the Guide catheter handle does not matc... Class II Medtronic Vascular, Inc.
Feb 27, 2017 Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Nu... Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endura... Class II Medtronic Vascular, Inc.
Oct 23, 2015 Amphirion Deep OTW PTA Balloon Catheter: Model numbers: US: AMP015020152 A... Medtronic has discovered that select lots of the Amphirion Deep PTA Balloon Dilation Catheter hav... Class II Medtronic Vascular, Inc.
Mar 3, 2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... Class II Medtronic Vascular, Inc.
Mar 3, 2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm,... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... Class II Medtronic Vascular, Inc.
Mar 3, 2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm,... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... Class II Medtronic Vascular, Inc.
Oct 7, 2013 Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Sten... A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Co... Class II Medtronic Vascular, Inc.
Sep 16, 2013 NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; M... Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the ... Class II Medtronic Vascular, Inc.
Sep 19, 2012 Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic ... Firm received reports of difficulty in flushing the graft cover of the delivery system during dev... Class II Medtronic Vascular, 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.