Tag: enroute_transcarotid_neuroprotection_system

FDA Issues Class I Recall for Boston Scientific ENROUTE Catheters

26 Aug 2026 11:16 a.m. · Source: US Food and Drug Administration

The FDA has issued a Class I recall for Boston Scientific's ENROUTE Transcarotid Neuroprotection System and Plus, citing potential for serious injury or death. This urgent action requires removal of affected percutaneous catheters from use.

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