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Guidant Finds More Defibrillator Problems

June 25, 2005
Guidant Corp. is warning doctors to stop using five defibrillator models because they could malfunction and may have to be recalled. It's the second safety announcement in a week from Guidant, which earlier recalled seven defibrillator models.

• 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

The devices included in the latest recall are the Contak Renewal 3 and 4, Renewal 3 and 4 AVT and Renewal TF, the U.S. Food and Drug Administration (FDA) said.

The agency said that four malfunctions have been confirmed and a fifth is suspected. In the four confirmed incidents, patients or physicians were alerted to the condition by audible tones that signaled the magnetic switch was closed.

The four devices have been replaced and there have been no documented patient injuries.

Guidant said physicians should reprogram the defibrillators so their magnet use is off. The devices will continue to function. Patients who hear beeping tones from the defibrillators, however, should go to the emergency room immediately.

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