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INDIANAPOLIS, IN - Dow Jones Newswires reported Guidant Corp. voluntarily advised doctors about a possible degradation in the hermetic sealing component used in some of its pacemakers, and said it received one death report. The medical technology-company advised the U.S. Food and Drug Administration (FDA) of its action, and expects FDA to classify the effort as a recall. Guidant said the problem could result in a higher-than-normal moisture content within the pacemaker case late in the device's service life. Many of the devices in question are nearing or have exceeded their estimated longevity. As of July 11, Guidant identified 69 devices that may have exhibited a failure mode out of the about 78,000 distributed pacemakers. The advisory concerns the Pulsar, Pulsar Max, Pulsar Max II devices, and Discovery and Discovery II. It covers Meridian, Contak TK, Intelis II, and Virtus Plus II. The pacemakers were made from Nov. 25, 1997 to Oct. 26, 2000. These products, which use an earlier design, haven't been sold or implanted for the last four years. The latest advisory is in addition to the FDA's decision, in mid-June, to recall some of Guidant's implantable cardiac defibrillators after Guidantr said it planned to advise physicians about the safety of its Ventak Prizm 2 DR, Contak Renewal, and other devices.

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