Home / Recalls / Medical Devices
Boston Scientific Corporation recalls Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Recalled August 26, 2026 · FDA recall Z-2978-2026 · Boston Scientific
Hazard
Potential for arterial sheath tip separation or partial tip separation during use. · FDA Class I
Units
49,229 units
Sold at
Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica
Description
Potential for arterial sheath tip separation or partial tip separation during use.
Product
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →