Guidant claimed responsibility for 12 deaths connected to malfunctioning Ancure units, although those who are familiar with Ancure claim that the actual number of deaths related to the defective product is at least 28. In April 2001, the FDA sent a letter to health care professionals who had used Ancure, warning them that "serious problems that have occurred" with the device. On June 12, 2003, a company official admitted in Federal Court that Guidant hid key facts about its product from the public. The company also pleaded guilty to nine counts of introducing a misbranded medical device with the intent to defraud or mislead.

 

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