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Heart Device Recalls – More Concerns Reported

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Boston Scientific Corp. reports that it has alerted doctors that another 996 Guidant defibrillators may quit unexpectedly, leaving heart patients at risk of sudden cardiac death.

No deaths or injuries have been reported as related to the battery failures, the company said Monday. The defect, a faulty low-voltage capacitor, was fouund in 30 defibrillators removed from patients as of May 8, and is suspected in at least 46 devices still in patients, per Boston Scientific’s statement said.

The defibrillator models affected by the capacitor problem are the Vitality DS, Vitality AVT, Vitality 2, Contak Renewal 3 and 4, and the Contak Renewal 4 AVT. The products were manufactured in March 2005 and all used a capacitor from a single supplier, the company told patients. In a letter to patients, the Guidant unit advised doctors to schedule in-clinic appointments for patients as soon as possible to check the batteries of those devices.

Boston Scientific said it learned of the failures after purchasing Guidant Corp. on April 21. U.S. regulators imposed sanctions on Guidant in December because of quality-control flaws after the recall last year of 109,000 defibrillators linked to at least seven deaths. Many recalled devices were sold years after Guidant learned of the flaws and began making models free of the problem.

“This is much better than Guidant did,” said Rob Faulkner, an analyst with JMP Securities in New York, about the disclosure. “This is very organized. If the others had been like this, there wouldn’t have been a problem because you know exactly to whom it applies.”

Glenn Reicin, an analyst with Morgan Stanley in New York, called Monday’s announcement a “non-event.”

“We would not be surprised to see further physician notifications, as the company enhances its efforts to remain transparent as well as support the recently issued Heart Rhythm Society guidelines,” Reicin wrote in a note to clients. “We continue to believe that Guidant device performance is generally in line with its competitors. We think the difference in Guidant’s case is the level of disclosure.”

Boston Scientific shares fell 13 cents Monday to $20.57. The shares have dropped 8.5 percent since the acquisition and 16 percent this year.

Personal injury attorneys in Florida have been advertising for defective heart devices cases for over year now, and new reports keep coming in.