Early Alert: Percutaneous Catheter Issue From Boston Scientific

Boston Scientific is alerting users about a potential issue with ENROUTE Transcarotid Neuroprotection Systems where the arterial sheath tip may separate or partially separate during use. This affects medical professionals and patients who use or have received this device. The company has issued an early alert about this defect.

Recalling firm

Boston Scientific

Product

Percutaneous Catheter

Reason

ENROUTE Transcarotid Neuroprotection Systems may have arterial sheath tip separation or partial tip separation during use

Category

medical device recall

Country

United States

Agency

FDA-MEDWATCH-RSS

Recall date

2026-07-24

Status

Ongoing

Official recall notice from FDA-MEDWATCH-RSS

Recall details on Nibble Recalls: https://trynibble.app/recalls/ed22cf67-89c2-4e01-bf1a-ae7a029442e0