HEALTH
INDIANAPOLIS — Guidant Corp. said Friday it was telling doctors to stop
using five models of its implantable cardiac defibrillators because a
faulty switch could cause it to malfunction.
The announcement was the Indianapolis-based company's second safety
advisory in a week for its defibrillators and covered two devices that
last week it said could be repaired with reprogramming in a doctor's
office. The company's shares tumbled 9.4 percent, or $6.42, to $62.18 in
morning trading on the New York Stock Exchange.
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 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, smaller than a pack of cigarettes, 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 shareholders in April approved a $25.4 billion acquisition by
Johnson & Johnson.
©2005 The Associated Press. All rights reserved.
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