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Boston Scientific ENROUTE Transcarotid Neuroprotection System recall

Boston Scientific Corporation recalled Boston Scientific ENROUTE Transcarotid Neuroprotection System on August 26, 2026 because of potential for arterial sheath tip separation or partial tip separation during use. It was sold nationwide.

Why it was recalled

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

What's recalled

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

Quantity: 115,458 units

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Boston Scientific Corporation, Maple Grove, MN
Date
Severity
Class I · most serious
the most serious: the product could cause serious health problems or death.
Where sold
Nationwide
Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Australia, Canada, China, Jamaica
Status
Ongoing
Recall number
Z-2977-2026
Source
U.S. Food and Drug Administration

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