FDA Early Alert: Percutaneous Catheter Issue from Boston Scientific

Published: 07/24/2026

Sources:
  • Food and Drug Administration
Relevant To:
  • Ambulatory Surgical Centers,
  • Rural Emergency Hospitals,
  • Critical Access Hospitals,
  • Hospitals

The Food and Drug Administration (FDA) is aware that Boston Scientific has issued a letter to affected customers recommending certain percutaneous catheters be removed from where they are used.

  • The ENROUTE Transcarotid System is designed to transport emboli away from the carotid artery circulation by reversing blood flow at the treatment site prior to crossing a lesion in the carotid artery and during lesion manipulation.

Reason for the Alert:

Boston Scientific stated they are init…

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