On June 11, 2009, the U.S. Food and Drug Administration alerted patients that it has recalled certain Medtronic Kappa and Sigma pacemakers based on the pacemaker’s tendency to fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.

This recall affects approximately 21,000 of the Kappa and Sigma pacemakers implanted in patients worldwide. Most of the devices affected by the recall have been implanted in patients five years or longer and fall under the following lot numbers:

• Kappa Series 600/700/900
• Sigma Series 100/200/300

 

Patients with malfunctioning pacemakers may experience a return of symptoms associated with an abnormal heart rate, such as fainting or lightheadedness. In some cases, patients implanted with these defective pacemakers may experience serious injury such as heart failure which could lead to death. The FDA has classified this recall as Class I, indicating reasonable probability that the use of the device will cause serious adverse health consequences or death.

If you or someone that you know has been injured or worse as a result of being implanted with a defective Medtronic Kappa or Sigma pacemaker, please contact the law offices of Houssiere, Durant & Houssiere, L.L.P. to schedule a free consultation with an experienced attorney and medical expert. The staff at Houssiere Durant and Houssiere has decades of experience in bringing successful suits against medical device companies and is aggressively handling claims against Medtronic.