Boston Scientific Corp. is voluntarily recalling 85,000 TAXUS drug-eluting stents as well as 11,000 of its bare-metal stent systems due to a problem with balloon deflation during coronary angioplasty procedures.
The problem can result in serious complications, including death or the need for coronary artery bypass graft surgery. The company said it received reports of one death and 18 serious injuries associated with balloon deflation for the Taxus and two deaths and 25 serious injuries in the Express2 bare-metal system.
The action follows the July 2 recall of 200 Taxus stents for the same reason. The company has shipped more than 500,00 Taxus stent systems and 600,000 Express2 stent systems. The recall does not affect patients who have already received the stents as the problem is with the delivery system at the time of insertion, Boston Scientific said. As a result of the recall, the company postponed the July 19 announcement of its second quarter financial results and said it expected that impact of the recall would reverse sales by approximately $45 million.