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Setback for Boston Scientific

This article was originally published in The Silver Sheet

Executive Summary

Just as Boston Scientific was beginning to emerge from the quality control cloud it had been living under for the past couple years, FDA revealed Aug. 14 that the firm had initiated a Class I recall of its NexStent carotid artery stenting system. The company, which began the recall June 6, says it received complaints regarding detachment of the tip of the delivery system during the stenting procedure. Boston Scientific has taken extensive steps to revamp its quality systems in the wake of a January 2006 corporate warning letter ("The Silver Sheet" August 2008)
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