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Boston Scientific Corporation recalls Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
Recalled August 26, 2026 · FDA recall Z-2977-2026 · Boston Scientific
Hazard
Potential for arterial sheath tip separation or partial tip separation during use. · FDA Class I
Units
115,458 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, Material Number SR-200-NPS; Percutaneous catheter
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →