Quick Facts on the Medtronic Heart Lead Recall
- On October 15, 2007, due to reports of at least five patient deaths associated with defibrillator leads sold under the brand name Sprint Fidelis, Medtronic issued a recall of the product. Medtronic stated that the Sprint Fidelis leads were prone to cracking, with potentially life-threatening consequences.
- Your wallet card will specify the manufacturer of your defibrillator leads. The Sprint Fidelis leads that have been recalled have the model numbers 6949, 6948, 6931 and 6930.
- The recalled leads have been implanted in an estimated 235,000 patients since 2004. They are connected to defibrillators either made by Medtronic or by another defibrillator manufacturer such as Guidant or St. Jude for which Medtronic supplied the lead.
- In January 2007, Medtronic reportedly launched a $100 million marketing campaign promoting the safety of its heart defibrillators, some of which used the faulty leads-event though in 2006 and later in 2007 medical journals reported on early failures of the Sprint Fidelis lead.
- On October 16, 2007, U.S. Senator Charles Grassley called on officials at Medtronic and the Food and Drug Administration (FDA) to explain why “Medtronic took months to stop the sales of the faulty lead, even though the problem had been reported in a peer-reviewed journal months prior.”
- On October 19, 2007, the Wall Street Journal reported that the recalled Medtronic heart leads may pose a higher risk of fracture in younger adults and children, a group for whom the devices were often used because of their small diameter. While children are a small share of the patients who received the wires, the leads tend to come under greater stress in more-active people, including kids, adolescents and younger adults.
- On October 30, 2007, the Wall Street Journal reported that the Medtronic recall exposes a hole in the U.S.’s medical safety system.