Class I

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

Boston Scientific Corporation · July 9, 2026

Reason for Recall

Potential for arterial sheath tip separation or partial tip separation during use.

Distribution

Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica

States Affected

NATIONWIDE

Quantity Affected

115,458 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2977-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.