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FDA Upgrades Guidant Recalls

July 6, 2005
The Food and Drug Administration (FDA) has upgraded previous recalls of certain implantable defibrillators manufactured by Guidant Corporation, and recalled June 17, 2005 and June 24, 2005.

• Device Maker Charged With Unlawful Clinical Trials • Medtronic To Disclose Payments To Doctors • Medtronic Withdaws Defibrillator Wires • Guidant Settles Defibrillator Charges For $16.7 Million • Court Orders Guidant To Release Documents • FDA Warns Guidant About Its Heart Devices • Spitzer Sues Guidant for Hiding Defibrillator Defect • FDA Report Addresses Heart Device Malfunctions • Potentially Harmful Medical Devices Should Be Recalled, Public Citizen Tells FDA • FDA Knew Of Pacemaker Problems Before Recall • Guidant To Resume Defibrillator Sales • Guidant Recalls Pacemakers • Guidant Pacemakers May Be Recalled • FDA Upgrades Guidant Recalls • Guidant Finds More Defibrillator Problems • FDA Recalls Guidant Implantable Defibrillators • Company Withheld News of Flaw in Defibrillator • Medicare To Cover More Defibrillators

FDA has designated as “Class I” the recalls of the Ventak Prizm, 2 DR (manufactured on or before April 16, 2002) and Contak Renewal1 and 2 devices (manufactured on or before August 26, 2004)

A “Class I” recall is the highest priority recall. It consisted of a letter to physicians and patients, and was sent out on June 17. This recall is one in which there is a reasonable probability that, if a particular device is malfunctioning, the malfunctioning device will cause serious adverse health consequences or death.

“Malfunctions in these devices can lead to serious consequences and it’s important for patients to call their doctor for additional information and personalized advice,” said Daniel Schultz, MD, Director of FDA’s Center for Devices and Radiological Health. “However, it’s also important to understand that in most cases these defibrillators work well and save lives.”

FDA has designated as “Class II” the previously announced physician communications concerning Ventak Prizm AVT, Vitality AVT, Renewal AVT devices, Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF devices

A Class II recall is one in which the malfunctioning product may cause temporary or medically reversible adverse health consequences, however the probability of serious adverse health consequences is remote.

These recall classifications do not affect Guidant’s current recommendation to physicians and patients. Guidant recommends that physicians continue with normal follow-up patient visits at three-month intervals.

Neither Guidant nor FDA is making a recommendation as to whether individual patients should have their devices removed. Rather, both believe that decision is best made by consultation between patients and their physicians, based on the specific case history of each patient.

In certain cases, the risks associated with the surgery to explant the device will outweigh the extremely small risk of device malfunction.

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