FDA Issues Recall and Patient Warning for Artery Stints

The FDA and Boston Scientific have issued a recall and hence a patient warning regarding three carotid artery stents and delivery systems. The three products that were recalled are:

NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System, distributed from June 19, 2007, through May 5, 2008

The defective devices were recalled because the tip can come off during the procedure which can prolong the surgery, puncture the artery, possibly cause a stroke or result in emergency surgery to remove the tip. The FDA did say that there was no danger for stents already in place.

However, if consumers have a carotid artery stent procedure scheduled, it would be prudent to consult with their surgeon to see if he/she is aware of the recalled defective product and to make certain that another type stent is used during the procedure.