Guidant defibrillator recall becomes more urgent
THE ASSOCIATED PRESS
Published in the Asbury Park Press 07/2/05
INDIANAPOLIS — More than 20,600 Guidant Corp. cardiac
defibrillators recalled last month have a malfunction that could cause
serious injury or death, federal regulators said Friday in classifying the
devices as the most urgent recall priority.
The Food and Drug Administration is not
urging the recalled defibrillators be removed but recommended patients
contact their doctors to decide the appropriate next steps.
Indianapolis-based Guidant, which has a
$25.4 billion acquisition offer pending from New Brunswick, N.J.-based
Johnson & Johnson, recalled a series of defibrillators last month. The new
FDA action lists three models as Class I recalls, the most serious type — a
move that might help doctors in deciding how aggressively to notify and
treat their patients.
The FDA also said it was investigating how
Guidant notified the agency and the public of the problem, said Timothy
Ulatowski, the FDA's medical device compliance chief.
Eleven types of defibrillators made by
Guidant were the subject of safety warnings issued last month. About 87,600
defibrillators are implanted in patients worldwide.
Guidant CEO Ronald W. Dollens said in a
statement Friday that "the health and safety of patients is paramount" for
the company.
The devices, about the size of a
mini-cassette tape, sense an irregular heartbeat and shock the heart back
into proper rhythm. But these models can develop an internal short circuit
that prevents 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.
Guidant shareholders in April voted to
accept Johnson & Johnson's offer of $76 per share in cash and stock. As
problems with products emerged since then, analysts said they think that
price is too high.
© 2005 Asbury Park Press
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