Boston Scientific issued a recall of its Carotid Wallstent Monorail Endoprosthesis due to a manufacturing defect that could cause resistance during device withdrawal.
Affected units were found to have an inner lumen smaller than specified, creating a risk of resistance when removing the stent delivery system, according to an Aug. 22 news release from the FDA. The defect could result in blood vessel injury, stent damage or the release of debris that may cause a stroke.
The recalled stents are used to open narrowed carotid arteries and are typically placed using a catheter. Boston Scientific began notifying customers July 7, advising them to halt use of the affected devices, remove them from inventory and return them, the release said.
Six incidents requiring medical intervention have been reported.
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