FDA Announces Class I Recall of Certain Medtronic Pacemakers
On June 11, 2009, the FDA announced a Class I recall - a recall classification reserved for products whose continued use could lead to serious illness or death - of a small number of Medtronic Kappa and Sigma pacemakers. The recalled devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. This issue can lead to loss of rate response, premature battery depletion, loss of telemetry, or no output, potentially causing patient symptoms such as fainting and lightheadedness. Medtronic Inc. issued a letter to physicians alerting them to this problem on May 18th. The company communicated with patients via letter on May 27th.
It is estimated that the recall affects 21,000 of the approximate 1.7 million Kappa and Sigma pacemakers implanted worldwide. The affected pacemakers are Kappa Series 600/700/900 and Sigma Series 100/200/300. Patients with these models of Kappa and Sigma pacemakers can determine if their pacemaker is part of this recall by contacting Medtronic at 800-505-4636 or going to their Web site at http://www.KappaSigmaSNList.medtronic.com. Medtronic indicates that most of the devices in the potentially affected subset have been implanted for five years or longer and may be nearing normal elective replacement time.