Percutaneous Catheter Recall: Boston Scientific Removes Enroute Transcarotid Neuroprotection System
Recall Summary Boston Scientific is recalling ENROUTE Transcarotid Neuroprotection Systems because the arterial sheath tip may separate or partially separate during use. This device is used during carotid artery procedures to help protect the brain from debris. The recall affects patients who have received or may receive this device for transcarotid procedures.
- Recalling firm
- Percutaneous Catheter
- Product
- ENROUTE Transcarotid Neuroprotection Systems may have arterial sheath tip separation or partial tip separation during use. <br> <br>
- 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
- 2026-08-26
- Status
- Ongoing
Official recall notice from FDA-MEDWATCH-RSS
Recall details on Nibble Recalls: https://trynibble.app/recalls/3fda9ec0-dd53-4aae-88f3-a43da5e3d58b