Medtronic news

Martin & Jones has compiled the latest news on the Medtronic Sprint Fidelis leads recall. We hope you will find these resources helpful.

This page is updated frequently, so we encourage you to visit us often for up-to-date news on the Medtronic recall.

The nation's largest maker of implanted heart devices, Medtronic, said yesterday that it was urging doctors to stop using a crucial component in its most recent defibrillator models because it was prone to a defect that has caused malfunctions in hundreds of patients and may have contributed to five deaths.

The faulty component is an electrical "lead," or a wire that connects the heart to a defibrillator, a device that shocks faltering hearts back into a normal rhythm. The company is urging all of the roughly 235,000 patients with the lead, known as the Sprint Fidelis, to see their doctors to make sure it has not developed a fracture that can make the device misread heart-rhythm data.

Medtronic's decision to voluntarily remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety.

These electronic wires are prone to fracture in a small number of patients which can cause the defibrillator to deliver unnecessary shocks or not operate at all. Based on our initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured.

Medtronic recently provided doctors with important information about our Sprint Fidelis defibrillation leads (Models 6930, 6931, 6948, 6949). We have informed doctors who, according to our records, manage the care of patients with Sprint Fidelis leads.

A defibrillator system consists of a device implanted near the shoulder and one or more leads connecting the device to the heart. This information applies to Sprint Fidelis leads only, not implanted defibrillation or pacemaker devices.

If you have a Sprint Fidelis lead, your Patient ID card should contain one of the following 4 sets of numbers: 6930, 6931, 6948, 6949. These numbers may be shown at the beginning of a longer set of numbers on your ID card.