FDA MedWatch Safety AlertsOriginal article
Early Alert: Percutaneous Catheter Issue from Boston Scientific
RegulatoryENROUTE Transcarotid Neuroprotection SystemsNegative
AI Analysis
Summary
Boston Scientific's ENROUTE Transcarotid Neuroprotection System is subject to an FDA MedWatch early alert for potential arterial sheath tip separation or partial tip separation during clinical use.
Outcome Details
FDA MedWatch alert regarding arterial sheath tip separation or partial tip separation during use of ENROUTE system
Importance:6/10
Sentiment:
-0.80
device_safetyFDA_alertproduct_defectpercutaneous_cathetercardiovascular
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Published by FDA MedWatch Safety Alerts on July 24, 2026 4:00 AM