Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers
MedSun: Newsletter #38, July 2009

FDA Recall Notice

Medtronic and FDA notified healthcare professionals and patients of a Class I recall of Medtronic Kappa Series 600/700/900 and Sigma Series 100/200/300 pacemakers due to a failure of the devices to pace the heart. Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.

Additional Information:

Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers. FDA Recall Notice. May 18, 2009.

FDA Alerts Patients to Medtronic Pacemaker Recall. FDA Press Release. June 11, 2009.

Patients Alerted to Pacemaker Recall. FDA Consumer Information. June 11, 2009.

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