Guidant Tells Doctors To Not Use Five Defibrillator ModelsJun 24, 2005 | AP
Guidant Corp. on Friday issued its second safety advisory in a week about its implantable defibrillators, telling doctors to stop using five of its models because a faulty switch could cause them to malfunction.
The five devices included in the latest announcement are the Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF. About 46,000 of the devices are in use, the company said.
Guidant said doctors "should discontinue implants of these devices pending further notice."
The company said it had informed federal regulators of its action and that the U.S. Food and Drug Administration may classify it as a recall. Officials with the FDA were not immediately available for comment.
The devices listed Friday have had at least four malfunctions. A fifth suspected case has not been confirmed, but no patients have been injured, Guidant said.
Guidant's defibrillator division is based in Arden Hills, Minn.
Guidant last week said five other models had flaws. It said some of those devices have memory problems and can be reprogrammed without removal, but nearly 29,000 of the defibrillators - 20,000 implanted in U.S. patients - can't be fixed externally.
At least two patients with those defibrillators have died, and the company said those devices had failed at least 45 times.
An implantable defibrillator is intended to sense an irregular heart rhythm and shock the heart back into correct beating.
The five defibrillator models cited by Guidant on Friday have a magnetic switch that can become stuck in a closed position, preventing the device from treating irregular heart rhythms. The faulty switch can also limit a defibrillator's battery life.
"Guidant works diligently to create the most reliable products and services, enhance patient outcomes, and limit adverse events to patients," company spokesman Steve Tragash said in a statement. "The actions taken today and over the last several weeks reflect our commitment to expand physician and patient communication."
Guidant said physicians should reprogram the five defibrillator models included in Friday's announcement so that their magnet use is off. Patients who hear tones from the defibrillators should go to the emergency room immediately.
At least 74,900 Guidant defibrillators worldwide are now under a company warning. The Renewal 3 and 4 AVT models were included in both announcements, but Guidant did not provide a breakdown of how many of those devices were in use.