Corporate Compliance

Device manufacturer pays FDA $296M for not reporting safety issues

Compliance Monitor, April 7, 2010

Medical device manufacturer Guidant LLC pleaded guilty in a US District Court in St. Paul, MN, for violating the FDA regulations by not reporting faulty implantable cardioverter defibrillators, according to a Department of Justice press release.

The defibrillator monitors the electrical activity of a patient’s heart and sends an electrical shock to the heart when it detects any abnormal pattern. Any malfunction or operating failure can result in sudden death. In its guilty plea, Guidant admitted to making a false statement in a required submission to the FDA and failed to notify the agency of a correction Guidant made to the device in an attempt to reduce its health risk.

Guidant’s criminal penalty of $296 million is the largest penalty ever imposed on a device manufacturer for violating the FDA’s regulations.

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