Spectranetics Corporation recalls

11 recalls in our records from 2016 to 2025: 11 FDA medical devices.

Recalls with full detail pages

• FDA · Medical devicesClass IFeb 26, 2025

  Spectranetics Corporation medical device recall: Intact Vascular Tack Endovascular System

  Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of an artery by tacking damaged tissue to inner luminal surface, could…

Earlier and other recalls

These link to the official agency notice.

• FDA · Medical devicesClass IIDec 25, 2024

  Spectranetics Corporation medical device recall: Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code /… Official notice ↗

  Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.

• FDA · Medical devicesClass IIDec 20, 2023

  Spectranetics Corporation medical device recall: Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF… Official notice ↗

  Incorrect product labeling. Exterior product box label does not match internal pouch label.

• FDA · Medical devicesClass IINov 23, 2022

  Spectranetics Corporation medical device recall: Philips Laser System Official notice ↗

  Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proceed until…

• FDA · Medical devicesClass IIJul 20, 2022

  Spectranetics Corporation medical device recall: Philips Laser System Official notice ↗

  The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until code is…

• FDA · Medical devicesClass IIJun 3, 2020

  Spectranetics Corporation medical device recall: Bridge Occlusion Balloon Official notice ↗

  There is a potential for thrombus formation on balloons prepped and staged in the vasculature for long durations. All users, such as those performing lead extraction…

• FDA · Medical devicesClass IIDec 4, 2019

  Spectranetics Corporation medical device recall: Spectranetics AngioSculpt PTCA Scoring Balloon Catheter Official notice ↗

  The incorrect outer carton box was used for the product.

• FDA · Medical devicesClass IOct 4, 2017

  Spectranetics Corporation medical device recall: Spectranetics Bridge Occlusion Balloon catheter Official notice ↗

  Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.

• FDA · Medical devicesClass IIAug 9, 2017

  Spectranetics Corporation medical device recall: Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid… Official notice ↗

  Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the catheter when…

• FDA · Medical devicesClass IIDec 7, 2016

  Spectranetics Corporation medical device recall: Turbo Elite Atherectomy Catheter. Models: 410-152 Official notice ↗

  Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon…

• FDA · Medical devicesClass IIFeb 17, 2016

  Spectranetics Corp. medical device recall: 2.3mm Turbo-Power OTW Official notice ↗

  The product is labeled with an expiration date that is past its shelf life.

Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.