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Stent Recall From Boston Scientific

Boston Scientific Corp. has recalled a stent used for leg arteries because of deployment issues that could lead to emergency surgery. The stent currently is not available in the United States.

The recall is listed as a Class I event on the U.S. Food and Drug Administration’s (FDA) website.

“Complaints of no deployment and partial deployment have been received,” said a statement issued by the FDA. “This type of failure may result in vessel wall injury, increased procedure time and/or emergency surgery to remove the partially deployed stent.”

The FDA further stated that 505 devices are subject to this recall; Boston Scientific issued a letter to customers outside the United States regarding these products last month. Because deployment issues occur after stent delivery, Innova stents (self-expanding stents used in the arteries above the knee) that already have been implanted are not affected.

Boston Scientific is based in Natick, Mass.

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