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. |