Update to FDA Notification on Guidant Implantable Cardioverter Defibrillators

FDA has issued an update to the Preliminary Public Health Notification (PPHN) for clinicians concerning the recent Class 1 recall of the Ventak Prizm(r) 2DR and Contak Renewal(r) 1 and 2 Implantable Cardioverter Defibrillators manufactured by Guidant. The notification advises clinicians of the occurrence of additional clinical failures of the Contak Renewal(r) devices. There have been no additional clinical failures of the Ventak Prizm(r) 2DR device. The recommendations for physicians who have implanted these devices remain unchanged. This notification can be found here.