We are a law firm dedicated to helping those injured by Medtronic Sprint Fidelis Defibrillator Lead.
Medtronic Recall Lawsuit
Medtronic has voluntarily removed its Sprint Fidelis defibrillation lead from the marketplace following reports of fractured leads and several patients’ deaths. The Medtronic lead recall affects patients with specific model numbers of their leads which are contained on your patient ID card.
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 Medtronic Sprint Fidelis lead recall does not mean that every lead will break. However, patients are encouraged to contact their doctor to discuss the different options regarding how to best manage the potential for lead fractures and the complications of removal of the leads. The FDA is not recommending that all Medtronic leads that are part of this recall be automatically removed. Instead, patients should weight the benefits and risks of continuing to use the lead or removal with their doctor.
If a Sprint Fidelis defibrillator lead fractures, the lead can send false signals causing the defibrillator to deliver inappropriate shocks or jolts or a needed shock may not be delivered. There is currently no reliable test to determine which Medtronic leads will potentially fracture.
If you or a loved one has been injured by a defective Medtronic Sprint Fidelis lead please contact us for a free consultation and case review. A Medtronic lead recall attorney can go over your legal rights and options and evaluate any potential claims you may have. You may be entitled to compensation and we can help.
U.S. Food & Drug Administration Statement On Medtronic Sprint Fidelis Defibrillator
Medtronic Suspends Sprint Fidelis Defibrillation Leads (PDF)
U.S. FDA Class 1 Recall Report
If you or a loved one have been injured by the Medtronic Sprint Fidelis lead please contact us immediately. You may be entitled to compensation.
Following the Medtronic recall of their Sprint Fidelis leads the Food and Drug Administration (FDA) has been involved keeping patients informed of new information regarding the defective leads as it becomes available. The following Question and Answer sheet was released by the FDA to help consumers affected by the Medtronic lead recall.
Medtronic Recalls Sprint Fidelis […]
On June 11, 2008 Bridget Robb testified before the Senate Judiciary Committee regarding her experience with the Medtronic lead recall. Ms. Robb suffered 31 shocks as a result of a defective Sprint Fidelis lead manufactured by Medtronic. Ms. Robb tells her story and shows how important it is for manufacturers of dangerous and defective products to […]
Following the Medtronic recall of their Sprint Fidelis heart leads the FDA released a statement covering the background of the Medtronic leads and recommendations.
Neither the FDA, Medtronic, nor representatives of the Heart Rhythm Society, recommend the routine surgical removal of a fractured lead because removal carries risks. Instead, physicians should weigh the benefits and risks […]
On October 15, 2007, Medtronic, Inc. announced that it was recalling its Sprint Fidelis defibrillation leads. Medtronic announced that the recall was due to “the potential for lead fractures.” At the time of the recall, there were reports of at least five deaths associated with the defibrillator leads. The Food and Drug Administration classified the […]
As of October 2007, Medtronic was aware of at least 665 chronic fractures in returned Sprint Fidelis leads. The majority of these fractures (approximately 90%) have occurred in the anode or cathode conductors. The Medtronic Sprint Fidelis 6930 lead was included in the 2007 recall. There seems to be evidence that Medtronic has knowledge their […]