Carotid Wallstent Monorail Recalled Due to Manufacturing Defect

Boston Scientific has recalled its Carotid Wallstent Monorail endoprosthesis, used to treat narrowed carotid arteries, due to a manufacturing defect that increases the risk of resistance when operators remove the stent delivery system, according to a US Food and Drug Administration alert.

Affected devices have an inner lumen that is smaller than intended. As of July 29, 2025, the company reported six cases in which additional efforts were needed to recover the device, but no patients have died.

There is the potential, however, for serious harm. This may include injury to the blood vessel, stent damage, and embolization of debris resulting in stroke, the FDA said. The agency has identified this as a Class I recall, the most serious type.

Boston Scientific sent its customers an Urgent Medical Device Removal Letter on July 7, 2025, advising them to stop using the stents immediately and return any affected devices to the company.