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Guidant Endovascular Grafts
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Guidant Ancure Endograft System Malfunctions

The Guidant Ancure Endograft System, used to repair abdominal aortic aneurysms, has been linked with 12 deaths and dozens of serious injuries.

According to the Justice Department, employees of the graft's maker, Guidant Corporation, actively concealed malfunctions of the device from patients, doctors and regulators.

Guidant Corp. has agreed to plead guilty to ten felony counts for concealing that the Ancure Device failed in 2,686 patients, including twelve who died and fifty-seven who required additional surgeries to repair problems. The number of concealed problems becomes more shocking in light of the fact that Guidant sold only 7,632 of the devices between 1999 and 2001.

The medical device maker will pay $92.4 million in fines, a record penalty for failing to report malfunctions to regulators. According to spokesmen for Guidant, the company has already set aside more than $90 million in the past two quarters to cover the fines, and while this is a large amount, it is dwarfed by Guidant's 2002 net income of $611.8 million.

Seven employees of Guidant alerted federal officials to the cover-up through an anonymous letter sent to the FDA. In the letter, the employees outlined the problems encountered with the Ancure Device as well as Guidant's failure to file the proper reports with the FDA. The letter, a copy of which the seven employees also sent to Guidant, outlined the various ethical, legal and safety concerns they believed Guidant ignored in its marketing of the Ancure Device.
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To contact us, please fill out the form below or call us at 1-800-275-0192.

If you or a loved one has suffered injury or fear potential complications as a result of procedures using the Guidant Ancure System, contact us.

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