Medical devices manufacturer EndoVascular Technologies Inc., a subsidiary of Guidant Corp., agreed to pay $92.4 million to settle federal civil and criminal charges and pleaded guilty to 10 felonies, including covering up thousands of incidents in which its product, known as the Ancure Endograft System, malfunctioned and making a false statement to the Food and Drug Administration. The Washington Post reports that twelve patients died, and dozens needed emergency.
“Because of the company’s conduct, thousands of patients underwent surgeries without knowing the risks they faced, and their doctors — through no fault of their own — were unprepared to deal with those risks,” U.S. Attorney Kevin V. Ryan said in a news release.
The Washington Post reports that about one third of the devices shipped by EndoVascular malfunctioned before the device was recalled and corrected two years ago.
Guidant said in a statement that “no patient with the . . . implant is at risk as a result of this matter.” More than 18,000 patients worldwide have been implanted with the device, which went back on the market with FDA approval in 2001, the company said.
(via Washington Post)
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