medtronic recall
Medtronic Recall
defibrillator leads recall
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Medtronic Defibrillator Settlement

December 21, 2007—Medtronic reached an agreement to settle more than 2,600 lawsuits alleging injuries from cardiac defibrillators.

Batteries in the Medtronic Marquis defibrillators were prone to shorting, prompting a recall in February 2005

The problems associated with the Marquis defibrillators are separate from those associated with the Medtronic Sprint Fidelis lead.

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Your Legal Rights

If you or a loved one has received a defective Medtronic heart device, you may be entitled to compensation.

You should act immediately to contact a lawyer experienced in matters involving defective medical devices.

Defibrillator Leads May Fracture, Risking Serious Injury or Death
medtronic sprint fidelis

October 15, 2007—Medtronic announced a recall of its Sprint Fidelis defibrillator leads after numerous reports of device failures leading to serious injuries and at least five deaths. An estimated 235,000 people have been implanted with the Medtronic Sprint Fidelis leads.

Leads are used to link a defibrillator or pacemaker to the patient's heart. Medtronic reports that the device can fracture after implantation, delivering a painful and potentially deadly electrical jolt to the patient.

Medtronic estimates that 2.3% of patients with these affected leads will experience failure within 30 months of implantation. Those people whose devices fail face a risk surgical procedure to remove the defective leads. Most patients who received Medtronic defibrillators since 2004 have the defective Sprint Fidelis leads.

Patients with Medtronic defibrillators should refer to their Patient ID card to determine whether the leads for their device are affected by the recall. The recall includes the following models:

  • Model 6930
  • Model 6931
  • Model 6948
  • Model 6949
Sprint Fidelis Leads Used Often With Medtronic Defibrillators Implanted Since 2004

medtronic recall

The problems with the Sprint Fidelis leads reportedly were brought to the company's attention in early 2007 by Dr. Roger G. Hauser of the Minneapolis Heart Institute. Dr. Hauser played a critical role in uncovering problems related to defibrillators manufactured by Guidant.

Medtronic officials told Dr. Hauser there was not enough information to reach any conclusions about the safety of the leads. It later warned doctors in a March 2007 letter of potential problems with the devices. Medtronic waited until October 2007, however, to issue a recall of the defective leads.

Medtronic has said it will not pay for procedures to replace the leads, and only would pay $800 to those patients whose devices failed and require surgical removal.

What You Should Do
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If you or a loved one has been implanted with a Medtronic Sprint Fidelis lead subject to recall, promptly consult your physician for an evaluation.
Our Lawyers Can Help

O'Steen & Harrison, PLC presently is investigating legal claims on behalf of those affected by defective Medtronic heart devices. We invite you to contact us for a free, confidential consultation about your legal right.

We will represent patients throughout the United States. We can help you, too, wherever you live.

For free answers to your questions about the Medtronic recall, please call us toll-free at 1-800-883-8888 or complete this online contact form.