VENTAK PRIZM 2 DR devices are subject to the Guidant recall and are defective due to a deterioration in a
wire insulator within the lead connector block. This deterioration, when it occurs in conjunction with other factors,
can lead to an electrical short, resulting in the device's inability to deliver therapy.
There have been at least 28 reports of failure of the VENTAK PRIZM 2 DR device worldwide, including one reported death.
These reports were from a total of 26,000 devices built prior to April 2002. No failures have been noted in the device built after April 2002.
Approximately 17,000 of the potentially defective devices built before April 2002 are still in service, including 13,900 in the United States.
Guidant has recommended that physicians follow up with the patients who have received the VENTAK PRIZM 2 DR devices.
Also, any patient who recently has received a defibrillation shock from this device should contact their physician immediately.
If the patient and physician decide to replace the device, Guidant will provide the replacement at no charge.
Back to list of Guidant defective products.
