Boston Scientific Recalls NexStent Products

-Reuters

08/17/2008- Boston Scientific Corp is recalling its NexStent carotid artery products because part of the stent's delivery system can detach and cause injury, U.S. health officials said on Thursday.

The recall, which includes NexStent products made from June 2007 to May 2008, does not affect stents that have already been implanted, the Food and Drug Administration said.

The tip of the device used to implant the stent can break off and may damage the blood vessel wall or lead to stroke, the FDA said in a notice on its website. The problem could also require emergency surgery to remove the tip.

Representatives of the company were not immediately available to comment.

NexStent was approved in October 2006 to help keep the neck's carotid arteries propped open after they have been cleared of fatty blockages.

The stent uses one of two delivery systems called the Monorail and Over the Wire, according to the FDA. The recall applies to the Monorail system as well as the stent itself.

Boston Scientific notified its customers about the recall in June, the agency said.

It was not immediately clear how much money NexStent has earned for the company, which did not break out specific sales figures in its 2007 annual report. The stent, which features a rolled mesh design for flexible sizing, was launched in February of 2007.

Shares of the Boston Scientific were off 4 percent at $12.84 in afternoon trade on the New York Stock Exchange.

The FDA posted the recall notice on its website here (Reporting by Susan Heavey and Debra Sherman; editing by Tim Dobbyn)