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Browse Device Recalls

12 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 12 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 12 FDA device recalls.

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DateProductReasonClassFirm
Jan 10, 2025 Intact Vascular Tack Endovascular System, to treat vascular dissections with ... Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of a... Class I Spectranetics Corporation
Nov 25, 2024 Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product ... Due to complaints received for the marker band detaching from the distal tip of the catheter and ... Class II Spectranetics Corporation
Nov 15, 2023 Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159 Sp... Incorrect product labeling. Exterior product box label does not match internal pouch label. Class II Spectranetics Corporation
Oct 14, 2022 Philips Laser System, REF: LAS-100. Used in minimally invasive interventiona... Laser System may detect Error 106 or Error 108 System Failures that will cause the system to ente... Class II Spectranetics Corporation
Jun 1, 2022 Philips Laser System, REF LAS-100, Intermittent Operation, Duty cycle depende... The LAS-100 Laser system may detect an inoperable hardware component during power up, which resul... Class II Spectranetics Corporation
Mar 31, 2020 Bridge Occlusion Balloon, REF 590-001, QTY 1, Sheath Compatibility 12F, Guide... There is a potential for thrombus formation on balloons prepped and staged in the vasculature for... Class II Spectranetics Corporation
Dec 7, 2018 Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diamet... The incorrect outer carton box was used for the product. Class II Spectranetics Corporation
Aug 7, 2017 Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Gu... Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a pot... Class I Spectranetics Corporation
Jun 6, 2017 Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchang... Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite At... Class II Spectranetics Corporation
Oct 31, 2016 ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-00... Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Cath... Class II Spectranetics Corporation
Oct 31, 2016 Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159,... Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Cath... Class II Spectranetics Corporation
Oct 31, 2016 Bridge Occlusion Balloon. Model: 590-001 Temporary vessel occlusion of the s... Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Cath... Class II Spectranetics Corporation

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.