Boston Scientific has recalled its Carotid Wallstent Monorail endoprosthesis owing to a “manufacturing defect” that has led to devices having an inner lumen that is smaller than specifications, causing resistance when withdrawing the stent delivery system.
A US Food and Drug Administration (FDA) recall notice dated 22 August states that 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 such, this recall has been identified as “the most serious type”, with continued use of the device potentially causing serious injury or death.
As of 29 July 2025, Boston Scientific has reported six cases that required additional intervention to recover the device, but has not reported any deaths associated with this issue.
The US FDA recall notice states that, on 7 July, Boston Scientific sent all affected customers an urgent medical device removal letter recommending that they immediately stop using affected devices; remove affected devices from inventory, and clearly segregate and return them to Boston Scientific; complete and return a reply verification tracking form, even if no affected devices remain; and share this information with all staff, facilities and customers who may have received the product.
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.
More details on the US FDA’s device recall notice can be seen here.
