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Guidant expands pacemaker recall
The company says seals in thousands of the devices could fail. Guidant is in the middle of a bidding war.
Associated Press
Published January 24, 2006
INDIANAPOLIS - Medical device maker Guidant Corp. on Monday expanded its pacemaker recall, saying seals in some models failed at a higher rate than originally reported and that thousands of other devices could have the same problem.
The news came as Guidant waited to hear from Johnson & Johnson, which faces a deadline today to respond in its bidding war with Boston Scientific Corp. for the Indianapolis company.
Guidant told physicians that 145 cases have been reported out of 16,000 pacemakers that were part of a July recall, raising the failure rate from 0.17 to 0.51 percent to a new range of 0.31 to 0.88 percent.
The failures occurred in a hermetic seal designed to keep out moisture.
Guidant also said another batch of pacemakers might have a similar problem because of a manufacturing mix-up that included faulty components with those that worked correctly. About 54,000 of those pacemakers were made, but only 19,300 remain implanted.
Among those, Guidant said it had identified about 2,500 devices with susceptible components. The failure risk in that batch was estimated at between 0.02 and 0.06 percent.
Pacemakers, which send electrical pulses to the heart to correct a slow heartbeat, have a seven- to 10-year life span before they must be replaced.
Several patients have lost consciousness or developed possible heart failure because of the faulty seal, the company said.
Monday's announcement effects Guidant's Contak TR, Discovery, Discovery II, Intelis II, Meridian, Pulsar, Pulsar Max, Pulsar Max II and Virtus Plus II models made between 1997 and 2000.
"It's certainly not positive," said John Putnam, an analyst with Stanford Group Co. in Boca Raton. "It's certainly indicative of a more serious problem."
Guidant will replace the devices - about the size of two half dollars held together - at no charge through June 30.
The company also said it would reimburse patients up to $2,500 for medical expenses.
Monday's announcement is the latest in seven months of safety advisories and recalls from Guidant, which has also issued warnings about 88,000 defibrillators and more than 200,000 pacemakers.
[Last modified January 24, 2006, 00:55:20]
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