Guidant Recall | Guidant Contak Renewal 1 and 2

Guidant Contak Renewal (Model H135) and Contak Renewal 2 (Model H155)

Guidant Devices

	Information on the Warning from Guidant
	Guidant Corp. initially warned physicians about problems with the Guidant Contak Renewal and Contak Renewal 2 on June 17, 2005. On July 1, 2005, the FDA classified the warning as a Class I recall. This type of recall occurs when the FDA concludes there is a "reasonably probability that if a particular device is malfunctioning, the malfunctioning device will cause serious adverse health consequences or death."
	Problem
	Deterioration in a wire insulator can result in a short in the device, causing a failure of the device.
	Reports of Injuries
	As of December 14, 2005, Guidant Corp. announced they had received 21 reports of failure worldwide, including five deaths.
	Models
	The problem affects the Contak Renewal Model H135 and Contak Renewal 2 Model H155 defibrillators manufactured on or before August 24, 2004.
	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.
	Documents
	US Advisory Update to June 17 Letter Guidant Corp. September 12, 2005 Letter to Patients Guidant Corp. June 24, 2005 Urgent Medical Device Safety Information & Corrective Action Guidant Corp. June 17, 2005

Our Lawyers Can Help You

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 Contak Renewal and Contak Renewal 2, just call us toll-free at 1-800-883-8888 or submit this online contact form.