A wholly-owned subsidiary of Boston Scientific Corp., which formerly did business as Guidant Corp., Guidant LLC was charged in district court in St. Paul, Minn., with criminal violations of the U.S. Food, Drug and Cosmetic Act.
The charges were filed following a four-year investigation into Guidant's handling of short-circuiting failures of three models of implantable cardioverter defibrillators -- the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155). Guidant issued safety advisories regarding the failures in June 2005, U.S. Justice Department officials said.
Guidant concealed information from the U.S. Food and Drug Administration regarding catastrophic failures in some of its lifesaving devices, officials said.
Once surgically implanted, the implantable defibrillators monitor the electrical activity in a patient's heart for deadly electrical rhythms and deliver an electrical shock to the heart in an effort to return the heartbeat to normal. If they fail to operate properly when needed, a person can die within minutes.
In a media release in November, Boston Scientific said it would pay $296 million on behalf of Guidant in connection with the charges.
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