The FDA issued an alert on July 24, 2026, regarding specific lots of Boston Scientific’s ENROUTE Transcarotid Neuroprotection and Neuroprotection Plus Systems. The warning identifies a risk where the device’s arterial sheath tip can separate during use.
This defect could lead to serious complications including embolism or stroke. Surgical intervention may be required to retrieve separated components from patients.
Boston Scientific initiated a voluntary removal of the affected lots on July 9, 2026. The company sent customer letters on that date instructing a halt to device use and the return of all affected units.
The company reported one serious injury and no deaths related to the issue as of July 9. The FDA is currently reviewing the matter and will provide further updates as information becomes available.