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U.S. Department of Health and Human Services

Safety

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Boston Scientific Express2™ (bare metal) Coronary Stent

Audience: Cardiologists, operating room supervisory personnel, and risk managers

FDA and Boston Scientific Corporation notified healthcare professionals of a Class 1 recall of the Boston Scientific Express2TM (bare metal) coronary stent system. Characteristics in the design of this stent system resulted in failure of the balloon to deflate and impeded removal of the balloon after stent placement. Impeded balloon deflation can result in significant patient complications, including emergency coronary artery bypass graft surgery and death. Hospitals should immediately discontinue use of any affected units.

[July 22, 2004 Recall Notice - FDA]