Medtronic is recalling 21,000 pacemakers sold under the Kappa and Sigma brand names because wires that connect the devices' electronic circuit to other components may fail, the U.S. Food and Drug Administration warned Thursday.
Although more than 1.7 million Kappa and Sigma pacemakers have been implanted in people, only about 21,000 devices are affected by the recall, mostly those that have been in patients for at least five years, the agency said.
People whose pacemakers malfunction may have a return of symptoms of abnormal heartbeat, including fainting and lightheadedness, the FDA said. In rare cases, a malfunction could lead to serious injury or death, the agency warned.
Medtronic issued a letter last month alerting doctors of the problem.
Affected devices are Kappa Series 600/700/900 and Sigma Series 100/200/300. People in whom these pacemakers are implanted should contact Medtronic at 1-800-505-4636, or visit its Web site at www.KappaSigmaSNList.medtronic.com to figure out if their devices are included in the recall.