Expanded Taxus recall
This article was originally published in The Gray Sheet
Executive Summary
Boston Scientific recalls roughly 85,000 paclitaxel-eluting stent systems and 11,000 Express2 bare-metal stent systems, citing balloon-deflation defects in some related delivery catheters. The company reports one death and 18 serious injuries associated with Taxus, and two deaths and 25 serious injuries linked to Express2 implants. In a Class I recall July 1, the firm withdrew 200 units but subsequently determined that many more Taxus and Express2 products - manufactured at Boston Scientific's Galway, Ireland and Maple Grove, Minn. facilities - also may have faulty balloon catheters (1"The Gray Sheet" July 5, 2004, p. 24). The expanded recall will cost $45 mil. in reversed sales in Q2, plus $50 mil. in written-down inventory, the firm gauges in a July 16 release...
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