FDA MedWatch Safety AlertsOriginal article
Percutaneous Catheter Recall: Boston Scientific Removes ENROUTE Transcarotid Neuroprotection System
RegulatoryENROUTE Transcarotid Neuroprotection SystemNegative
AI Analysis
Summary
Boston Scientific has recalled the ENROUTE Transcarotid Neuroprotection System due to potential arterial sheath tip separation or partial tip separation during use, a significant safety concern for this interventional device.
Outcome Details
Arterial sheath tip separation or partial tip separation during use
Importance:6/10
Sentiment:
-0.80
product recallmedical devicesafety issuepercutaneous catheter
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Published by FDA MedWatch Safety Alerts on August 26, 2026 4:00 AM