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U.S. Department of Health and Human Services

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Guidant VENTAK PRIZM 2 DR and CONTAK RENEWAL Implantable Cardioverter Defibrillators

Audience: Cardiologists and other healthcare professionals

[UPDATE December 29, 2005] FDA issued an update to the July and October, 2005, Preliminary Public Health Notification. The updated PPHN provides numbers of deaths and serious injuries for the three devices as of December 12, 2005. FDA's recommendations have not changed.

[Posted 07/18/2005] FDA issued a Preliminary Public Health Notification and advice for patients for Guidant VENTAK PRIZM 2 DR and CONTAK RENEWAL Implantable Cardioverter Defibrillators to provide clinicians with current information and guidance concerning malfunctions occurring with these devices, which were the subjects of a Class I recall announced by FDA on July 1, 2005. The malfunction that is the subject of the recall causes damage to the device’s circuitry, potentially resulting in the inability to deliver the required shock during episodes of arrhythmia. This malfunction could lead to a serious, life-threatening event. Importantly, the device does not give any sign of impending failure, and there is no test that predicts whether any particular device will fail. The affected devices are:

VENTAK PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004.

[December 28, 2005 UPDATE- Preliminary Public Health Notification - FDA]
[October 13, 2005 UPDATE- Preliminary Public Health Notification - FDA]
[July 18, 2005 - Recall Notice for Ventak PRIZM 2 - FDA]
[July 18, 2005 - Recall Notice for CONTAK RENEWAL and CONTAK RENEWAL 2 - FDA]
[July 14, 2005 - Preliminary Public Health Notification - FDA]
[July 15, 2005 - Advice for Patients - FDA]

Previous 2005 MedWatch Safety Alert