FDA Media Alert Detail

FDA Safety Alert

Percutaneous Catheter Recall: Boston Scientific Removes ENROUTE Transcarotid Neuroprotection System

  • U.S. Food and Drug Administration
  • August 26, 2026
  • ID: http://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/percutaneous-catheter-recall-boston-scientific-removes-enroute-transcarotid-neuroprotection-system

FDA MedWatch Safety Alert

ENROUTE Transcarotid Neuroprotection Systems may have arterial sheath tip separation or partial tip separation during use.


Content syndicated from the official FDA MedWatch Safety Alerts and Adverse Event Reporting Program.