A Class 1 recall was initiated on Monday, October 15th, 2007 by the U.S. Food and Drug Adminsitration and Medtronic, Inc. for Sprint Fidelis Defibrillator Leads. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
These leads are being recalled because a small number of fractures have been detected. When the lead breaks (fractures), it may cause inappropriate shocks or result in a loss of therapy, such as pacing or shocking. A flaw acknowledged late Sunday by the manufacturer Medtronic, Inc. involving a lead wire commonly used with its defibrillators has resulted in some patients receiving shocks over and over again when they don't need them.
Leads are thin wires that connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. ICDs and CRT-Ds are devices that are used to treat abnormal heart rhythms that can cause the heart to stop suddenly.
Leads such as the Sprint Fidelis product are used to connect pager-sized defibrillators, implanted near the shoulder, to the hearts of patients. Defibrillators work by shocking the heart to restore its normal rhythm, and an estimated 235,000 patients currently are using the Sprint Fidelis leads.
Medtronic has advised doctors to stop implanting these leads and to return unused products to the firm. Patients who are implanted with this lead or do not know the model of their lead, should contact their physicians for further information.
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
If you or a loved one has suffered injuries or have legal concerns related to these products, please contact us via our Free Claim Evaluation via this Contact Us link. You may be legally entitled to recover medical expenses, lost earnings, as well as compensation for physical pain and suffering, mental anguish and physical impairment. For persons who have died, their surviving spouse or other family members often can bring a wrongful death action.
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