FDA Announces Recall for Boston Scientific Stent System

Mark Crane

Disclosures

June 20, 2011

June 20, 2011 — Boston Scientific Corporation has recalled its Innova Self-Expanding Stent System for a potentially life-threatening defect, the US Food and Drug Administration (FDA) announced June 17.

The system, intended for use in the treatment of symptomatic de novo or restenotic lesions in the native superficial femoral artery and/or proximal popliteal artery, was recalled because of complaints of no deployment and of partial deployment.

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 said. The recall does not affect stents that have already been implanted, as the risk occurs during delivery of the stent.

Boston Scientific, based in Natick, Massachusetts, sent an urgent medical device recall letter to its customers on May 13. The class 1 recall notice identified more than 500 over-the-wire self-expanding stent system devices, required distributors to cease further distribution and use of the product, and requested the return of unused product to Boston Scientific.

A list of affected serial numbers for the recalled system is available on the FDA Web site.

Class 1 recalls involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death, the FDA said.

This is the second class 1 recall for Boston Scientific disclosed by the FDA last week. The agency announced a recall of more than 100,000 iCross intravascular ultrasound imaging catheters because the catheter tip can break inside of the patient, causing tissue and blood vessel injury, heart attack, or other serious events requiring additional unplanned surgery.

Adverse events related to the Innova Self-Expanding Stent System should be reported to MedWatch by telephone at 1-800-332-1088, by fax at 1-800-332-1078, online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm, or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20857.

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