FDA Updates Preliminary Public Health Notification: Guidant VENTAK PRIZM and CONTAK RENEWAL ICDs (12/2005) — FDA has issued an update to the July and October, 2005, Preliminary Public Health Notification (PPHN), "Guidant VENTAK PRIZM(r) 2DR and CONTAK RENEWAL(r) and RENEWAL(r) 2 Implantable Cardioverter Defibrillators. Learn more.
Update to FDA Notification on Guidant Implantable Cardioverter Defibrillators (11/13/2005) — 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. Learn more.
FDA Issues Preliminary Public Health Notification Regarding Guidant VENTAK PRIZM 2 DR and CONTAK RENEWAL ICDs (07/15/2005) — The preliminary public health notification issued by the FDA on July 14, 2005, provides clinicians with current information and guidance concerning the malfunctions of the above-named ICDs. Learn more.
FDA Updates Consumers on Guidant Corporation's Implantable Defibrillators (07/01/2005) — The FDA issued a statement on July 1, 2005, regarding the recent ICD recalls. View the press release.
FDA Posts Guidant Press Release Regarding Safety Information and Corrective Action About ICDs (06/25/ 2005) —The FDA issued Guidant's press release on June 24, 2005, regarding the safety information and corrective recalls of certain devices. View the press release.
Washington Report: FDA Announces Guidant's Class I Pacemaker Recall (03/25/2005) —The U.S. Food and Drug Administration's (FDA) notified the health care providers and patients regarding the Guidant Corporation's voluntary recall of certain pacemakers. The FDA has classified Guidant's action as a Class I recall. Learn more.