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Medical Device

Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter

Recall date: 2026-08-26 · Source: FDA_DEVICE
Brand / Firm
Boston Scientific Corporation
Product
Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
Reason for recall
Potential for arterial sheath tip separation or partial tip separation during use.
Units affected
115,458 units
Description
Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
View official recall notice →