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.
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm166344.htm

FDA Alerts Patients to Medtronic Pacemaker Recall. FDA Press Release. June 11, 2009.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm165853.htm

Patients Alerted to Pacemaker Recall. FDA Consumer Information. June 11, 2009.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm165619.htm


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