Boston Scientific Recalls Carotid Stents Over Safety Risks

Boston Scientific has issued a recall of its Carotid Wallstent Monorail Endoprosthesis after discovering a manufacturing defect in the delivery system. The flaw created an inner lumen smaller than specifications, leading to increased resistance during stent withdrawal. According to the FDA, this could damage blood vessels, impair the stent, or release debris that may cause a stroke.

The recall covers 26,570 devices worldwide, including 1,333 in the U.S. As of July 29, six cases required additional medical intervention, though no deaths were reported. The FDA classified the recall as Class I, its most serious category, citing the risk of severe injury or stroke.

Boston Scientific has instructed customers to immediately stop using, remove, and return the affected devices. First approved in 2008, the carotid stent is used to open narrowed arteries. This is the first recall entry for the product since a coating process change was cleared last year.

29-08-2025