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Medtronic in hot seat over Fidelis recall

This article was originally published in The Silver Sheet

Executive Summary

Medtronic's decision last month to halt worldwide distribution of its Sprint Fidelis defibrillator leads has attracted congressional scrutiny of the company's response to data showing the leads were vulnerable to fracture. The attention, reminiscent of that surrounding Guidant's ICD recalls in 2005, stems from Medtronic's Oct. 15 announcement advising physicians to stop implanting four models of Fidelis leads and return unused product to the company. FDA, which classified the recall as Class I, began closely monitoring Fidelis in February when cardiologist Robert Hauser, M.D., of the Minneapolis Heart Institute contacted FDA about problems with the lead's performance. "What I find troubling is that Medtronic took months to stop the sales of the faulty lead, even though the problem had been reported in a peer-reviewed journal months prior," Sen. Chuck Grassley, R-Iowa, wrote to Medtronic CEO Bill Hawkins Oct. 16. Grassley and House Committee on Oversight and Government Reform Chair Henry Waxman, D-Calif., have also sent letters to FDA requesting information on the agency's oversight of Medtronic's Fidelis leads

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