Guidant expands pacemaker recall
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 Tuesday deadline to respond in its bidding war with Boston Scientific Corp. for the Indianapolis-based 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 mixup that included faulty components with those that worked correctly. About 54,000 of those pacemakers were originally made, but only 19,300 remain implanted.Among those, Guidant said it had identified about 2,500 devices with susceptible components.The failure risk in that batch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 lifespan 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, Fla. “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, 2006. The company also said it would reimburse patients up to $2,500 for medical expenses. Pacemakers are implanted during a short surgery when an incision is made near the shoulder.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.Despite its regulatory and legal problems, the company is at the center of an ongoing bidding war between Boston Scientific and Johnson & Johnson.A five-day deadline for New Brunswick, N.J.-based J&J to sweeten its $24.2 billion acquisition offer for Guidant ends Tuesday afternoon. Guidant’s board of directors has said a $27.2 billion counter offer from Natick, Mass.-based Boston Scientific is superior.Guidant shares rose 12 cents to $76.07 in afternoon trading on the New York Stock Exchange.