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Medtronic Sprint Fidelis® Defibrillator Lead Recall Lawsuit

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Medtronic has suspended sales of the Sprint Fidelis® family of defibrillator leads because of the potential for lead fractures, reports of at least 5 patient deaths and other serious, life-threatening complications.

The Sprint Fidelis® lead has been implanted in approximately 268,000 people worldwide. The Sprint Fidelis® lead may have also been used to connect defibrillators manufactured by other companies such as Guidant, Boston Scientific, and St. Jude.

The U.S. Food & Drug Administration (FDA) is recommending that patients who have had the Sprint Fidelis® lead implanted should contact their physician immediately, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations.

If you or a loved one have been injured by the Medtronic Sprint Fidelis® lead, you should contact us immediately. You may be entitled to compensation and we can help.

What’s the problem?

On October 15, 2007 Medtronic announced it was voluntarily suspending distribution of its Sprint Fidelis® defibrillation leads because of reports of fractures leading to serious complications including at least 5 deaths.

"Fractures in the Sprint Fidelis leads may lead to audible alerts, inappropriate shocks and the loss of output," Medtronic said.

Medtronic first notified physicians in March 2007 about the fracture rate at that time and the proper method for implantation. Additional data on adverse events accumulated since then has prompted the Sprint Fidelis® recall.

Medtronic Sprint Fidelis® Recall List

The following model numbers of the Sprint Fidelis® family of defibrillator leads have been recalled:

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

The Sprint Fidelis lead may have also been used to connect defibrillators manufactured by other companies such as Guidant, Boston Scientific, and St. Jude.

Signs of Lead Fracture / Breakage

In the circumstance where a lead malfunctions, 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.

Do I have a Medtronic Sprint Fidelis® Lawsuit?

The Medical Device and Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in Medtronic lawsuits. We are pursuing individual litigation nationwide and currently accepting new Medtronic Sprint Fidelis® defibrillator lead cases in all 50 states.

Attention Attorneys: We do not publish prior verdict/settlements. If you are an attorney and would like to refer us a case or for us to send you a profile of prior award judgments or average referral fees, please visit the attorney referral section of our website.

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Medtronic Recall & Lawsuit News (National)

Medtronic issues voluntary recall of certain heparin-coated products (Sharewatch)
SAN FRANCISCO (Thomson Financial) - Medtronic Inc. late Wednesday issued a "voluntary and precautionary" recall of certain disposable heparin-coated products that are used in cardiopulmonary bypass for heart surgeries.

Medtronic Initiates Voluntary Field Actions For Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (Medical News Today)
Medtronic, Inc. (NYSE: MDT) announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs.

Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (Centre Daily Times)
Medtronic, Inc. (NYSE: MDT) today announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass (CPB) for heart surgeries. Affected products include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. This action is being taken ...

Medtronic Initiates Voluntary Field Actions for Selected Heparin-Coated Products Used During Cardiopulmonary Bypass (Business Wire via Yahoo! Finance)
MINNEAPOLIS----Medtronic, Inc. today announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda BioActive surface. The affected devices are disposable products used during cardiopulmonary bypass for heart surgeries.

Medtronic recalls heparin-coated bypass equipment (Reuters via Yahoo! News)
Medtronic Inc said on Wednesday it was voluntarily recalling some disposable devices used during cardiac bypass surgery because they have been found to be coated with contaminated traces of the blood-thinner heparin.

Medtronic recalls heparin-coated devices (Post-Bulletin)
MINNEAPOLIS -- Medtronic Inc. says it is recalling some devices used in heart bypass surgery because their coating includes contaminated heparin, a blood thinner that has been linked to 81 deaths. Most of the heparin recalled by oth

Medtronic pulls some heparin-coated devices (AP via Yahoo! Finance)
Medtronic Inc. says it is recalling some devices used in heart bypass surgery because their coating includes small amounts of contaminated heparin, a blood thinner that in larger doses has been linked to 81 deaths.

Medtronic recalls some bypass devices (Minneapolis-St. Paul Star Tribune)
Medtronic Inc. of Fridley is recalling some devices used in heart bypass surgery because their coating includes small amounts of contaminated heparin, a blood thinner that in larger doses has been linked to 81 deaths.

Medtronic pulls some heparin-coated devices (Minnesota Public Radio)
Medtronic Inc. says it is recalling some devices used in heart bypass surgery because their coating includes contaminated heparin, a blood thinner that has been linked to 81 deaths.

Regional Report / Medtronic recalls some heparin-coated devices (Pioneer Press)
Medtronic Inc. said it is recalling some devices used in heart bypass surgery because their drug-coating includes small amounts of contaminated heparin, a blood thinner that in larger doses has been linked to 81 deaths.



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