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Medical Device Manufacturer Guidant Charged in Failure to Report Defibrillator Safety Problems to FDA
Date:2/25/2010

Boston Scientific Subsidiary Charged with Federal Crimes Related to June 2005 Defibrillator Recalls

WASHINGTON, Feb. 25 /PRNewswire-USNewswire/ -- Medical device manufacturer Guidant LLC, a wholly-owned subsidiary of Boston Scientific Corporation, was charged today with criminal violations of the Federal Food, Drug, and Cosmetic Act related to safety problems with some of its implantable defibrillators. Guidant LLC formerly did business as Guidant Corporation. The Justice Department filed the criminal information today in connection with an agreement with Guidant to resolve the charges. A formal guilty plea agreement is expected to be filed with the court at a later date. Boston Scientific previously announced in a November 2009 press release that the company would pay $296 million on behalf of Guidant in connection with these charges.

According to the information filed today in federal district court in St. Paul, Minn., Guidant concealed information
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SOURCE U.S. Department of Justice
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