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U.S. Department of Health and Human Services

Safety

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Medtronic Micro Jewell II Model 7223Cx and GEM DR Model 7271 Implantable Cardioverter Defibrillators

Audience: Cardiologists and other healthcare professionals

The FDA notified healthcare professionals of a Class I recall of implantable cardioverter defibrillators (ICDs) from Medtronic Inc. of Minneapolis, Minnesota. Some Medtronic ICDs were found to have defective high voltage capacitors that may take longer than normal to charge near the end of the battery service life and could cause a delay in delivery or a non-delivery of shock therapy. This could result in patient injury or death because patients are not receiving the appropriate therapy in time. A total of 6,268 of the affected ICDs were manufactured, of which about 1,800 are thought to be still implanted in patients worldwide. Patients with Medtronic ICDs with these model numbers should contact their physicians for further information and advice.

[April 4, 2004 - Recall Notice - FDA]
[April 16, 2004 - Press Release - Medtronic]