Boston Scientific is recalling the Carotid WALLSTENT Monorail Endoprosthesis due to a manufacturing defect that created an inner lumen smaller than specifications, causing resistance when withdrawing the stent delivery system.
Using the affected stent systems could cause serious harm, such as injury to the blood vessel, damage to the stent or release of debris that could travel to the brain and cause a stroke.
As of July 29, 2025, Boston Scientific has reported six cases that required additional intervention to recover the device. The FDA said the company has not reported any deaths associated with this issue.
Boston Scientific is urging all affected customers to immediately stop using affected devices; remove affected devices from inventory, clearly segregate, and return to Boston Scientific; share information with all staff, facilities, and customers.
The Carotid WALLSTENT Monorail Endoprosthesis is a self-expanding stent used to open narrowed carotid arteries and is placed using a catheter over a guidewire or embolic protection device.
FDA
