FDA Sat on Heart Device InfoQuicklink submitted by Amanda Lang Permalink
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|The U.S. Food and Drug Administration was warned about problems with Guidants heart devices months before the agency issued a safety alert, according to a New York Times article Monday. As far back as February, the FDA received data showing the Indianapolis-based companys defibrillator product, the Ventak Prizm 2 DR, was short-circuiting. However, the FDA did not announce a recall of the device until July 1.|
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