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U.S. Department of Health and Human Services

Medical Devices

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Medtronic Inc. Sprint Fidelis® Defibrillator Leads

Class 1 Recall
Date Recall
Initiated
October 15, 2007
Product:

Medtronic Inc. Sprint Fidelis® Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949 manufactured from September 2004 through October 15, 2007.

 

Use:

Leads are thin wires that connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. ICDs and CRT-Ds are devices that are used to treat abnormal heart rhythms that can cause the heart to stop suddenly.

 

Recalling Firm:

Medtronic Inc.
7000 Central Avenue
Minneapolis, Minnesota 55432-3576

 

Reason for Recall:

These leads are being recalled because a small number of fractures have been detected. When the lead breaks (fractures), it may cause inappropriate shocks or result in a loss of therapy, such as pacing or shocking.

 

Public Contact:

Patients may contact Medtronic Patient Services at 1-800-551-5544 X41835 (7 am to 9 pm Central Standard Time).

 

FDA District:

Minneapolis

 

FDA Comments:

Medtronic has advised doctors to stop implanting these leads and to return unused products to the firm.

Patients who are implanted with this lead or do not know the model of their lead, should contact their physicians for further information.

Patients can read additional FDA Information related to this recall:

For more information about this recall, please see the company’s press release.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Health care professionals and consumers may report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program. See the nearby link to MedWatch.