FDA Puts Guidant Recall In Class 1Jul 2, 2005 | Star Tribune Guidant Corp. can't seem to get out of the bad-news column.
On Friday, the Food and Drug Administration placed three models of the company's implantable cardioverter defibrillators (ICDs) in its highest risk category.
The FDA's Class I ranking means users of the device could suffer death or serious injury if the device fails. Guidant advised physicians about the possibility of problems with the devices last week.
"Malfunctions in these devices can lead to serious consequences, and it's important for patients to call their doctor for additional information and personalized service," said the FDA's Dr. Daniel Schultz, director of the agency'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."
The FDA said it was not making a recommendation to remove and replace the affected ICDs. It said that decision should be made by patients and their physicians because replacement itself could pose a risk. Two deaths in a population of 42,000 implanted patients have been reported. About 21,000 of the ICDs remain implanted.
Now listed as a Class 1 recall are three models: Ventak Prizm 2 DR (model 1861), Contak Renewal (model H135) and Contak Renewal 2 (model H155.) The devices sense an irregular heartbeat and shock the heart back into proper rhythm. But those models can develop an internal short circuit that prevent them from working.
The problem is caused by deterioration of electrical insulation in the device, and there's no way to predict which ones will fail, the FDA said.
The FDA gave Class II status to eight other models of Guidant ICDs. Class II means a user could suffer temporary or medically reversible injuries if the device fails.
Guidant's headquarters are in Indianapolis, but its Cardiac Rhythm Management division is based in Arden Hills.
Wall Street has been watching Guidant's recall woes very carefully in light of its pending acquisition by health care behemoth Johnson & Johnson for $25.4 billion.
In trading Friday, Guidant's shares dropped $1.57 to close at $65.73.
Information already disclosed
But industry analysts said Friday's FDA-related news was only a reiteration of information that Guidant already had disclosed. Its effect on the J&J transaction? "Zero," said Thomas Gunderson of Piper Jaffray.
"It's all just about semantics," Gunderson said of the FDA announcement. "The news is out. The 'damage' has been done. The valuation has been imputed. I wasn't surprised, and Johnson & Johnson is smarter than me. I don't think Johnson & Johnson cares what the FDA calls them."
The FDA is investigating how Guidant notified the agency and the public of the problem, said Timothy Ulatowski, FDA's medical device compliance chief.
"We are continuing to evaluate the circumstances surrounding the notification by Guidant," he said. The agency will announce its findings in "a matter of weeks, not months."
Listed as a lower-priority Class II recall Friday are the Guidant models Ventak Prizm AVT, Vitality AVT and Renewal AVT. About 21,000 of those devices are implanted worldwide, including 18,000 in the United States. There are two confirmed malfunctions with those models; neither resulted in injury, the FDA said. Guidant has said this defect can be detected and fixed non-invasively.
Also given a Class II priority are Guidant's newest models, the Contak Renewal 3 and 4, Renewal 3 and 4 AVT and Renewal RF brands. A magnetic switch may become stuck, inhibiting the ability to treat certain irregular heartbeats unless doctors fix it, also possible non-invasively. Four such malfunctions have been confirmed among about 46,000 implanted devices; a fifth is suspected, FDA said.
Tones sounded by the device signal the malfunction; a patient who hears those tones should go to the emergency room, the FDA said.