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Guidant Expands Recall

January 24, 2006|From Associated Press

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-based company.

Guidant told physicians that 145 cases had been reported out of 16,000 pacemakers that were part of a July recall, raising the failure rate from a range of 0.17% to 0.51% to a new range of 0.31% to 0.88%. 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 0.02% to 0.06%.

Pacemakers send electrical pulses to the heart to correct a slow heartbeat. Several patients have lost consciousness or developed possible heart failure because of the faulty seal, the company said.

Monday's announcement affects Guidant's Contak TR, Discovery, Discovery II, Intelis II, Meridian, Pulsar, Pulsar Max, Pulsar Max II and Virtus Plus II models made from 1997 to 2000.

Guidant will replace the devices 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.

Guidant shares rose 5 cents to $76.

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