FDA recall Z-2977-2026

Boston Scientific Corporation · Class I · device

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2026-07-09
Report date
2026-08-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Maple Grove, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2977-2026