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  • Medtronic Lead Recall Overview
    Medtronic Lead Recall Overview

    On October 15, 2007, Medtronic, a Minnesota corporation, announced it was recalling its Sprint Fidelis brand of defibrillation leads. Medtronic said the recall was because of “the potential for lead fractures.” At that time, there were reports of at least five deaths associated with the defibrillator leads. The FDA certified the recall as “Class 1.” A Class 1 recall is the most serious type because it involves situations where there is a reasonable probability that the use of the product will cause death or serious injury.

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