Medtronic Recall

In October 2007, Medtronic issued a recall of its Sprint Fidelis defibrillation lead from the marketplace following increasing 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 Sprint Fidelis defibrillator leads model numbers that have been recalled include:

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

The Medtronic Sprint Fidelis lead recall does not mean every lead will fracture or break causing a malfunction. However, Medtronic and the FDA are encouraging patients to contact their doctor to go over the different options regarding the best way to handle 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 are advised to weigh the risks and benefits of leaving the lead implanted 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.