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FDA Classifies Previously Announced Medtronic Physician Advisory On Small Subset Of Kappa And Sigma Pacemakers As Class I Recall
Medtronic, Inc. (NYSE: MDT) announced the U.S. Food and Drug Administration (FDA) has classified Medtronic"s previously announced physician advisory about a small subset of Kappa® and Sigma® series pacemakers, identified at increased susceptibility for separation of bonded interconnect wires from the electronic circuit, as a Class I recall. Notification to U.S. FDA, physicians and patients began May 18, 2009. As of the date of this news release, more than 95 percent of physicians following affected devices in the United States have confirmed receipt of the notification. The FDA"s classification of Medtronic"s Important Patient Safety Information does not alter the patient management recommendations already provided in the May 2009 letter, and physicians need not take any new action.