Due to a flaw in a crucial component in its most recent defibrillator models, Medtronics stated that the device was prone to malfunctions in hundreds of patients and may have contributed to five deaths.

The U.S. Federal Drug Administration (FDA) announcement on October 15, 2007 that Medtronic Inc. Sprint Fidelis® Defibrillator Leads (model numbers 6930, 6931, 6948 and 6949) manufactured from September 2004 through October 15, 2007 were subject of a CLASS 1 RECALL. A Class 1 recall is the most serious type of recall and involves situations in which there is a reasonable probability that use of the product will cause serious injury or death.

Medtronic, Inc. then voluntarily suspended worldwide distribution of the Sprint Fidelis® family of defibrillation and advised against new implants of the leads.

The "leads" are tiny wires that connect the patients' hearts to the stopwatch-size defibrillators. Medtronic said the leads could fracture inside the patients' blood vessels, possibly causing the defibrillator to improperly send a massive electrical jolt to the heart. The defibrillators are designed to detect an irregular heartbeat and deliver one or more shocks to restore a normal rhythm. If the device discharges improperly, it can cause serious problems.

The Sprint Fidelis leads are used to deliver therapy in defibrillators only, including Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy – Defibrillators (CRT-Ds). According to Medtronic Inc., approximately 268,000 Sprint Fidelis leads have been implanted worldwide.