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U.S. Department of Health and Human Services

For Consumers

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Patients Alerted to Pacemaker Recall

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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 with the cited models of Kappa and Sigma pacemakers should determine if their pacemaker is part of this recall by contacting Medtronic at 1-800-505-4636 or going to the firm's Web site.

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.

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: June 11, 2009