Boston Scientific issues recall
Device Regulation Alert: Safety, Compliance and Reimbursement News, August 25, 2008
Boston Scientific voluntarily issued a Class I Recall of NexStent Monorail, NexStent Carotid Stent, and Monorail Delivery System, distributed from June 19, 2007, through May 5, according to an FDA MedWatch.
The device is used to treat carotid artery disease. Boston Scientific issued the recall because the tip of the stent delivery system may detach during the carotid artery stenting procedure, leading to increased procedure time, injury to the vessel wall, stroke or emergency surgery to remove the tip. The recall does not affect devices that have already been implanted.
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