Company ordered to pay $92 million in penalties
SAN FRANCISCO (AP) -- A medical device manufacturer faces $92.4 million in penalties after covering up malfunctions that may have led to 12 deaths during aneurysm treatments.
Endovascular Technologies Inc., a subsidiary of Indianapolis-based Guidant Corp., pleaded guilty to 10 felonies Thursday, including shipping misbranded products and making false statements to government regulators.
Investigators said they also may bring charges against executives of the company, which is based in Menlo Park, Calif.
The problems involving the Ancure "stent-graft" device, used during operations to treat abdominal aortic aneurysms, were resolved after the device was voluntarily recalled in March 2001 and before it was reintroduced five months later, the company said in a statement.
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