Medtronic and the FDA recently announced a Class 1 recall of approximately 21,300 Kappa and Sigma pacemakers manufactured primarily between November 2000 and November 2002. Patients can enter the serial number of their device at this Web site to find out whether it is included in the recall.
The reason for the recall is that the "devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery." In rare cases, patients who are pacemaker-dependent may experience serious injury or death resulting from the defect.
See further details on MedPage Today.
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