FDA Recalls 21,000 Faulty Medtronic Pacemakers

Law360 (June 11, 2009, 12:00 AM EDT) -- Medtronic Inc. is facing another recall, this time because of Kappa- and Sigma-brand pacemakers that the U.S. Food and Drug Administration said Thursday could fail because of wiring problems.

In the FDA's announcement of the Class I recall, it warned consumers and physicians that the pacemakers might fail because of a separation of the wires that connect the electric circuit to other components, including the battery.

The affected pacemakers may cause symptoms associated with abnormal heart rate, including fainting or light-headedness. In severe, but rare, cases...
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