Guidant Corp. initially warned physicians about problems with the Ventak Prizm 2 DR in May 2005.
Problem
Deterioration in a wire insulator can result in a short in the device, resulting in a failure of
the device.
Reports of Injuries
As of December 14, 2005, Guidant Corp. announced they had received 28 reports of this failure
worldwide, including two deaths. FDA records indicate that 14 of the known failures occurred in a relatively
short period between January 2004 and March 2005.
Models
The problem affects Model 1861 units manufactured before April 16, 2002.
Recommendation
Patients should consult with their physicians to discuss possible removal of the device.
Patients also should continue with ongoing monitoring to detect any problems with the device.
O'Steen & Harrison, PLC presently is handling legal claims on behalf of those injured by defective
Guidant heart devices.
For free answers to your legal questions about the Guidant Ventak Prizm 2 DR (model 1861), just
call us toll-free at 1-800-883-8888 or submit this online contact form.