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FDA Classifies Previously Announced Medtronic Physician Advisory on Small Subset of Kappa and Sigma Pacemakers as Class I Recall
Medtronic, 06/11/09

Medtronic, Inc. announced the U.S. Food and Drug Administration 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 2009.

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