Medtronic Recall Information

Medtronic Sprint Fidelis® Defibrillator Lead Recall

Medtronic Recall Information

On October 15, 2007 Medtronic announced it had voluntarily suspended distribution of the Sprint Fidelis Defibrillator Leads. The Medtronic leads were being recalled because of the potential for leads fractures. These lead "fractures" may be a possible or likely contributing factor to five deaths and other serious injuries reported to the FDA.

As of October 4, 2007 there have been 268,000 Medtronic Leads implanted worldwide, with 172,000 leads implanted in the United States.

The FDA has issued a Class 1 recall, the most serious type of recall. The Class 1 recall involves situations in which there is a reasonable probability that use of the Medtronic leads will cause serious injury or death. 

• Read FDA recall information
• FDA - Question and Answers for customers
• Read Medtronic release
• Read Patient letter (Dated: October 15, 2007)
• Read Additional Patient Letter (Dated: October 22, 2007)

How does a Medtronic Lead work?

Defibrillators are used to treat abnormal heart rhythms that can cause the heart to stop suddenly. The Medtronic Defibrillator Leads are used to deliver therapy in defibrillators only, including Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy - Defibrillators (CRT-Ds). These devices keep the heart from going too fast.

Medtronic Sprint Fidelis Defibrillator Recall models

The following model numbers of the Medtronic Spring Fidelis Defibrillator Leads have been recalled:

• Sprint Fidelis 6930
• Sprint Fidelis 6931
• Sprint Fidelis 6948
• Sprint Fidelis 6949
  
  

Signs of a Fractured Medtronic Lead

In the circumstance that a lead breaks or "fractures," the lead may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered. If you experience multiple shocks, lightheadedness, fainting, or palpitations please contact your physician immediately.

How do I know if I have a Medtronic Sprint Fidelis Difibrillator Lead?

You may have been sent a patient card that identifies the implanted device. In the event that you do not know the model number of your leads, you should contact your physician for more information.

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