Medtronic Pacemaker Recalled

The FDA has issued a Class I recall of Medtronic’s Kappa and Sigma pacemakers due to a separation in the electronic medical device. The 21,000 pacemakers recalled are the Kappa Series 600/700/900 and Sigma Series 100/200/300. According to the FDA, the recalled devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery
The Class I recall designation means that the FDA considers the defective medical device has a reasonable probability to cause serious injury or death.
The defect in the pacemaker may cause pacemaker patients to experience an irregular heartbeat and shortness of breath. Patients who are concerned about the pacemaker defect should contact their physician.