MedTech Intelligence – Read More

Press Release: MTI Staff was not involved in writing this content

Boston Scientific recalled 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. The company sent all affected customers an Urgent Medical Device Removal Letter on July 7, 2025 with recommended actions.

While Boston Scientific has reported six cases requiring additional intervention to recover the device, no deaths associated with this issue have been reported.

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. Using the affected stent systems, according to the FDA, however, 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.

The post Boston Scientific Vascular Stent Recall: Carotid WALLSTENT Monorail Endoprosthesis appeared first on MedTech Intelligence.