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FDA Sat on Heart Device Info

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The U.S. Food and Drug Administration was warned about problems with Guidant’s 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 company’s 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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