Pacemaker Connectors Recalled

Times Wire Services

One of the world's foremost manufacturers of pacemakers is recalling wire connectors that help the devices regulate heartbeat, because the wires could puncture their surrounding insulation and seriously damage the heart. Englewood, Colo.-based Telectronics Pacing Systems Inc. began the worldwide recall after learning that a woman with one of its pacemakers had died and that the wire inside her pacemaker was found to be defective, according to a story this week in the Denver Post. About 40,500 of the 42,000 so-called J leads made since 1987 have been implanted in patients with heart disease, including about 22,000 in the United States. The recall affects only the 1,500 or so leads that have been sold but not yet installed in pacemakers. Telectronics said it has formed a physicians advisory committee to consider what to do about the 40,500 patients with the pacemakers already implanted. The group will try to determine whether surgery would be more risky than leaving the devices intact. In November, Telectronics sent letters to 7,000 physicians known to have patients with pacemakers containing the defective part, and it set up a toll-free number for questions: (800) 349-9446.

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