WASHINGTON, June 11 (UPI) -- The U.S. Food and Drug Administration announced the recall of some Medtronic Inc. Kappa and Sigma pacemakers that might cause serious problems or death.
The FDA said the recalled devices might fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. The federal agency said patients with malfunctioning pacemakers could experience such symptoms as fainting or lightheadedness. In rare cases, the FDA said, pacemaker-dependent patients could experience serious injury or even death.
The FDA said Medtronic issued a May 18 letter to physicians alerting them to the problem and notified patients in a May 27 letter.
More than 1.7 million Kappa or Sigma pacemakers have been implanted in patients around the world, but only about 21,000 of them are affected by the recall.
The affected pacemakers are Kappa Series 600/700/900 and Sigma Series 100/200/300. Officials said patients with those models should determine if their pacemaker is part of the recall by contacting Medtronic at 1-800-505-4636 or going to their Web site at http://www.KappaSigmaSNList.medtronic.com.
The FDA said it classified the voluntary recall as Class I, indicating reasonable probability that the use of the device will cause serious adverse health consequences or death.
