Boston Scientific expands stent recall
Compliance Monitor, August 11, 2004
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Boston Scientific Corp. announced August 5 it expanded the recall on its Taxus Express2 Paclitaxel-Eluting Coronary Stent System to more than 3,000 additional systems.
The company first announced the voluntary recall of certain Taxus and Express2 stent systems in mid-July because aspects of the delivery catheters could potentially hamper balloon deflation during angioplasty.
Boston Scientific acknowledged the balloon deflation problem was the cause of one death and 22 serious injuries.
The company will alert institutions-primarily in the United States-who have affected units. It said patients who have already received stents are not at risk, because any difficulty associated with non-deflation occurs during the implantation procedure.
Federal regulators met with company officials August 6 to ask for additional data about the manufacturing defect that led to the recall, the Associated Press reported August 7.
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