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U.S. Department of Health and Human Services

Safety

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Boston Scientific Taxus Coronary Stent

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

FDA and Boston Scientific Corporation notified healthcare professionals of a Class I recall of two lots of the Taxus drug-eluting coronary stent system (lots 6294706 and 6365192). Characteristics in the design of these two lots 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.

[UPDATE August 6, 2004 - additional lots recalled]
[July 9, 2004 - Recall Notice - FDA]