Boston Scientific is recalling the Carotid Wallstent Monorail Endoprosthesis, according to a U.S. Food and Drug Administration (FDA) notice.
Due to a manufacturing defect that created an inner lumen smaller than specified, there is a risk of resistance when the stent delivery system is withdrawn.
“The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it,” the notice said.
The Carotid Wallstent Monorail Endoprosthesis, used during interventional radiological procedures to treat carotid artery stenosis, is a self-expanding stent used to open narrowed carotid arteries. It is placed using a catheter over a guidewire or embolic protection device.
Possible harm could result from using the affected stent systems, including injury to the blood vessel, damage to the stent, and release of debris that could travel to the brain and cause a stroke.
Boston Scientific sent an Urgent Medical Device Removal letter on July 7 to all affected customers, informing them of the recall, and instructing them to immediately stop using the devices, remove them from inventory, and return them to the company.
As of July 29, Boston Scientific has reported six cases requiring additional intervention to recover the device. The company has not reported any deaths associated with the issue.
