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Boston Scientific balloon recall

This article was originally published in The Gray Sheet

Executive Summary

Natick, Mass. firm announces the recall of the delivery systems for Flextome cutting balloon angioplasty devices on Dec. 8. An analysis indicates that the distal shaft of the delivery catheter may separate during withdrawal of the device, potentially prolonging an angioplasty procedure or forcing additional surgery. The firm is searching for the root cause of the problem, but until that analysis is complete, the products - which have generated $13 mil. so far this year - will remain off the market, according to a company spokesperson...
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