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Violation Tracker Individual Record

Company: Guidant LLC
Current Parent Company: Boston Scientific Corp.
Penalty: $296,000,000
Year: 2011
Date: January 12, 2011
Offense Group: safety-related offenses
Primary Offense: drug or medical equipment safety violation
Secondary Offense: product safety violation
Mega-Scandal: Medical Equipment Hazards
Violation Description: Guidant LLC, a wholly-owned subsidiary of Boston Scientific Corporation, was formally convicted and sentenced in St. Paul, Minn., before U.S. District Court Judge Donovan W. Frank for criminal violations relating to its interactions with the Food and Drug Administration (FDA). Judge Frank sentenced Guidant to pay more than $296 million in criminal fines and forfeiture and also to submit to the supervision of the U.S. Probation Office for three years. The Justice Department brought criminal charges against Guidant for its mishandling of short-circuiting failures of three models of its implantable cardioverter defibrillators: the Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155). Guidant's Cardiac Rhythm Management division, which produced the defibrillators, is headquartered in Arden Hills, Minn. The company pleaded guilty to the charges the previous April.
Level of Government: federal
Action Type: agency action
Agency: Food and Drug Administration referral to the Justice Department
Civil or Criminal Case: criminal
HQ Country of Current Parent: USA
HQ State of Current Parent: Massachusetts
Ownership Structure of Current Parent: publicly traded
Major Industry of Current Parent: medical equipment and supplies
Specific Industry of Current Parent: medical devices
Source of Data: (click here)
Source Notes: If an online information source is not working, check the Violation Tracker Data Sources page for an updated link.
Current parent company note: Parent-subsidiary relationship is current as of the most recent revision listed in the Update Log.