Medtronic Pacemaker Recall

On June 11, 2009, the U.S. Food and Drug Administration (FDA) alerted patients to the Class I recall of certain Medtronic Kappa and Sigma pacemakers.

Why was this recall necessary?

The recalled devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery.

Which pacemakers are being recalled?

The recall 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.

The affected pacemakers are
Kappa Series 600/700/900
Sigma Series 100/200/300

What is a Class I recall?

A Class I recall indicates reasonable probability that the use of the device will cause adverse health consequences or death.

How will patients know if their pacemaker is being recalled?

Patients who have these recalled pacemakers and those who are unsure if their pacemakers are affected should follow up with their primary care physician or cardiologist.

What symptoms should patients be on the lookout for?

Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death.

What overall actions have FDA and Medtronic taken in regard to these pacemakers?

Through standard medical device reporting requirements, FDA became aware of possible problems and worked with the company to address them. On May 18, 2009, Medtronic Inc. issued a letter to physicians, alerting them to the problem. The company followed up with a patient letter on May 27, 2009.

Medtronic Pacemaker Lawsuits

The attorneys at the Allen Law Firm are evaluating claims on behalf of individuals throughout the United States who are experiencing complications from recalled Medtronic Pacemaker Leads. 

If you or a loved one suffered serious injury or a loved one died as a result of a Medtronic Pacemaker you may be entitled to financial compensation.  Fill out the form on this page for a free Medtronic Pacemaker case evaluation.  A lawyer from our firm will call you as soon as possible to help you determine the possibility of filing a potential claim.  Or call 888.345.5291 to speak to an attorney about Medtronic Pacemaker cases now.

The initial consultation is free of charge.  In personal injury cases where individuals have been injured by potentially defective products like Medtronic Pacemakers, it is important to act quickly to preserve evidence and investigate the the injury.  Further, you must file a lawsuit before the statute of limitations expires.  If you delay filing your claim, and the statute of limitations expires, you may lose your rights to compensation.