The United States Department of Justice found that employees of the Guidant Corporation actively concealed malfunctions of the device from patients, doctors and regulators.

As a result the 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 Guidant Corp., the company has set aside over $90 million to cover the fines.

Seven Guidant employees informed government officials of the cover-up by sending an anonymous letter 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.