Hauser Calls Out the FDA, Guidant Corporation on Recalled Devices

It was the death of a 21-year-old patient whose implanted cardiac defibrillator failed to shock his heart back to normal rhythm that started Dr. Robert Hauser on the path to becoming a vocal advocate for change at the FDA. Joshua Oukrop, just a teenager when he received a Guidant ICD for a congenital heart condition, died when the implant shorted out instead of providing the necessary shock to his heart. Hauser looked for answers to why the implant might have failed, discovering in the process that there had been 26 other failures for the same device reported to the FDA, he told CBS News.

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