Boston Scientific Recall NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System

Boston Scientific has issued a Class I recall for their NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, due to a defect which could allow the tip of the stent delivery system to detach during a carotid artery stenting procedure.

The recalled stents are used to treat blockages in carotid artery disease. Carotid arteries, which are located on either side of the neck, supply blood to the brain.

During carotid artery stenting (CAS), the physician places the stent, which is self-expanding, in the artery to keep it open and to help prevent future narrowing which could disrupt blood flow.

The Boston Scientific carotid stent recall, which was posted on the FDA website August 14, 2008, was classified as a “Class I Recall” because the use of the potentially defective stents carries a reasonable probability of serious adverse health consequences or death.

If the tip of the stent delivery system detaches, it could cause a stroke, vessel wall injury, an increased amount of time to complete the procedure or an additional emergency surgery to remove the detached tip of the stent.

Boston Scientific manufactured the recalled NexStent Monorail, NexStent Carotid Stent and Monorail Delivery Systems between June 12, 2007, through May 2, 2008. However, the recall is only directed to cardiologists and medical providers, and does not apply to individuals who already have the carotid stent implanted. According to Boston Scientific, the problems are only known to occur during the stenting procedure.