Defibrillator Lead Recall

On October 15, 2007, Medtronic suspended sale of their Sprint Fidelis Defibrillator leads (Models 6930, 6931, 6948, 6949) after receiving reports of 5 fatalities.

Reports of fracturing of Sprint Fidelis leads on Medtronic implantable defibrillators had been piling up for months. As of January 2007, the Food & Drug Administration (FDA) had received 599 reports of lead fractures.

In March 2007, Medtronic wrote a letter to doctors warning them about possible problems with the defective leads. However, it was a full 6 months later before the company decided to postpone distribution on the Sprint Fidelis leads.

Despite having so many reports of Sprint Fidelis lead fractures, the FDA did not start monitoring the component until February, after the Minneapolis Heart Institute published a study of lead failures in the Sprint Fidelis models compared to the Sprint Quattro models, another type of Medtronic lead.

 

Free legal consultation

If you or a loved one have been injured by a defective heart lead, you may have a claim against the manufacturer of the Sprint Fidelis heart defibrillator lead.

Please contact us today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost no-obligation evaluation of your case.