Guidant Corp. subsidiary EndoVascular Technologies, Menlo Park, Calif., pleaded guilty to 10 felony counts and agreed to pay $92.4 million to settle criminal and civil charges that it covered up thousands of incidents in which a medical device used to treat aortic aneurysms malfunctioned. The U.S. attorney's office in San Francisco said the incidents involved 12 patient deaths and dozens of invasive surgeries. The 10 felony counts include nine for shipping misbranded products and one for making false statements to the Food and Drug Administration. The case represents the largest amount ever paid for failure to report device malfunctions to the FDA, and it's one of the first such cases involving a felony conviction, the U.S. attorney's office said. EVT and Guidant agreed to enter into a corporate integrity agreement with HHS' inspector general's office and said they will cooperate in the continuing investigation. EVT said it voluntarily recalled the product in March 2001, and the plea agreement involves only issues prior to the recall. "No patient with ... the implant is at risk as a result of this matter," the company said. -- by Cinda Becker
Guidant unit admits hiding problems with device
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