Medtronic Inc., the Minnesota based medical device maker, has recalled several models of its Sigma & Kappa pacemakers due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. Initially recalled in May 2009, the company has updated the recall information with recommendations to physicians and patients.
Sigma & Kappa pacemaker recall
Medtronic, which has a history of recalls over defective medical devices including:
Medtronic recently recalled its Sigma 100 / 200 / 300 series of pacemakers and its Kappa 600 / 700 / 900 series of pacemakers in May of 2009 because the implanted devices, which provide timed electrical stimulation to the heart to treat abnormally slow heart rhythm (bradyarrhythmia), may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.
The Class I recall, the most serious recall available, affects only 21,000 of the more than 1.7 million Kappa or Sigma pacemakers implanted in patients worldwide. Most of the devices affected by the recall have been implanted in patients five years or longer.
Physician & Patient Information
Medtronic has released updated information to physicians and patients since recalling the pacemakers. The company has created a “Device Identification Web Page for Kappa and Sigma Series Pacemakers
re: November 2005 and May 2009 Physician Communications” which allows physicians and patients to find out more about their particular pacemakers. To view the website, please click here. The company also sent out a patient letter. To view the letter, please click here.
Additional information
For additional information, contact Medtronic Patient Services directly at 1-800-551-5544. You can also consult with an experienced products liability lawyer to discuss your situation and evaluate your options.
