ENROUTE Transcarotid Neuroprotection Systems: Arterial Sheath Tip Separation Alert

The U.S. Food and Drug Administration (FDA) has issued an alert regarding Boston Scientific’s ENROUTE Transcarotid Neuroprotection Systems, citing reports of arterial sheath tip separation or partial tip separation during medical procedures. The issue involves the potential for pieces of the catheter tip to detach while the device is in use within a patient’s artery.

The alert was identified through regulatory monitoring on July 24, 2026, following reports that the percutaneous catheter system may experience structural failure at the tip. According to the FDA, these separations can occur as full or partial detachments of the arterial sheath tip during the delivery of the neuroprotection system.

The ENROUTE system is designed for use in transcarotid artery revascularization (TCAR) procedures. These procedures aim to reduce the risk of stroke during the carotid artery stenting process by utilizing a temporary reversal of blood flow to capture debris before it reaches the brain.

A separation of the sheath tip during such a procedure introduces the risk of a retained foreign body within the vascular system. If a piece of the catheter remains in the artery, it may lead to complications including vessel occlusion, embolism, or the need for additional surgical intervention to retrieve the detached fragment.

Medical professionals using the system are advised to monitor the integrity of the device throughout the procedure. The FDA alert emphasizes the necessity of verifying that the sheath tip is intact upon removal from the patient to ensure no fragments have been left behind.

Boston Scientific has not yet provided a detailed public timeline for a corrective action or a formal recall of specific lot numbers associated with these failures. The FDA continues to monitor reports of device malfunctions to determine if a broader systemic failure exists across different manufacturing batches of the ENROUTE system.

Healthcare providers are encouraged to report any adverse events or device malfunctions involving the ENROUTE Transcarotid Neuroprotection Systems through the FDA’s MedWatch reporting system to assist in the ongoing safety evaluation.