Medtronic Sprint Fidelis Recall List Medtronic Defibrillators Defibrillator Alert Possible Types of Defibrillator Lead Malfunctions Medtronic Defibrillator Leads Where Was the FDA? Medtronic Class Action Lawsuit Should I sue Medtronic? Medtronic Recall Lawyers Benifits of an Experienced Disability Attorneys Recall Notice

On October 15, 2007, the FDA announced a nationwide Medtronic recall for the Sprint Fidelis lead, which is an electrical wire that connects a defibrillator to the heart. The defective lead is prone to fracturing or breaking, which could result in a massive electrical shock or cause the defibrillator to not work when it is needed. The FDA classified the Sprint Fidelis recall as a "class 1" recall since the defect has a substantial likelihood to cause serious injury or death.  Any heart patients who have had a defibrillator implanted since 2004 should consult with their physician or check the patient information card given at the time the device was implanted. The Medtronic recall applies to the following leads:

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

The Sprint Fidelis lead was introduced by Medtronic in 2004. It was developed in a rush to compete with other cardiac device companies by having a more compact and flexible product. It replaces their thicker lead, known as the Sprint Quattro, which was introduced in 2001. Metronic has received reports of individuals experiencing severe electrical shocks as a result of their defibrillator firing when it was not needed, and at least five deaths could have been caused by the faulty lead wire. A recall was issued following a review of data from a clinical trial involving 650 individuals at 17 hospitals, and a review of pooled data for 25,000 patients collected from CareLink, a system Medtronic has for monitoring implants.

Approximately 268,000 of the recalled Medtronic leads are already implanted in patients. According to industry analysts, the Sprint Fidelis lead is used on about 60% of all Medtronic defibrillators implanted, but it could also be used with other defibrillators manufactured by companies like Boston Scientific/Guidant or St. Jude. It is not used with pacemakers.

The attorneys at Carabin & Shaw P.C. are investigating claims for compensation for individuals who have the Sprint Fidelis lead. As a result of the defective wire which was placed in their chest, Medtronic has forced them to face a future of concern about whether their device will suddenly malfunction. If you, a friend or family member believe you may have this lead, request a free consultation. Any defibrillator implanted since 2004 could have a Sprint Fidelis lead. Medical records and patient information cards can be reviewed to determine if you may be eligible for compensation. There is no obligation to hire a lawyer, and there are no fees or expenses unless a recovery is obtained. Call us toll free at 1-800-862-1260.

TRADEMARK NOTICE: Sprint Fidelis is a trademark of Medtronic Corporation.

The Carabin & Shaw Law Firm, its' lawyers and this website is in no way affiliated with Medtronic Corporation. The use of this mark is solely for informational and product identification purposes.