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August 2008
Company:
Boston Scientific
Product:
NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System
Boston Scientific and FDA informed healthcare professionals and patients of the Class I Recall of NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, distributed from June 19, 2007, through May 5, 2008. The device is used in patients to treat a blockage in carotid artery disease. The product was recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure. This could lead to increased procedure time, cause vessel wall injury, stroke and/or emergency surgery to remove the detached tip. The recall does not affect stents that have already been implanted.
 
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