Loading Curie Briefs...
Getting the latest healthcare news for you
Getting the latest healthcare news for you
The FDA has escalated its alert to a Class I recall — its most serious classification — for Boston Scientific's ENROUTE Transcarotid Neuroprotection System after a manufacturing defect was found to cause arterial sheath tip separation during use. The flaw could lead to stroke, embolism, or other serious vascular complications. Over 164,000 units across two device models are affected, and hospitals have been told to stop use immediately.
The FDA has issued a Class I recall — its most serious category — for Boston Scientific's ENROUTE Transcarotid Neuroprotection System, a device used to prevent emboli from reaching the brain during transcarotid artery revascularization (TCAR) procedures. The recall was triggered by a manufacturing defect that can cause the arterial sheath tip to separate during use, potentially leaving a fragment inside the patient that requires surgical or endovascular retrieval.
Boston Scientific first notified customers on July 9, 2026, urging them to immediately stop using the affected catheters and return them. The FDA had initially issued an Early Alert on July 24 before upgrading it to a full Class I recall. One serious injury has been reported so far, with no deaths.
By the Numbers:
Why it matters: TCAR is an increasingly used alternative to open carotid endarterectomy, particularly in high-surgical-risk patients. A defect in the neuroprotection system — the very device designed to prevent stroke during the procedure — raises significant patient safety concerns. Hospitals should audit their inventory immediately, noting that affected devices may be catalogued under the Silk Road Medical brand name.
