Boston Scientific Corp., Natick, Mass., is recalling two balloon delivery systems, one of which was only recently approved for marketing by the Food and Drug Administration, saying the distal shaft of the catheter used in the systems could separate during withdrawal. Separation can prolong the artery-clearing surgery or may lead to additional surgery. The company said it received eight complaints involving patients, and three of the patients required more surgery. About 40,000 devices will be recalled. The systems generated $13 million in revenue so far this year. Boston Scientific, which earlier this made a $25 billion bid for Guidant Corp., said the recall will not affect its other balloon products.
Boston Scientific recalls two balloon systems
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