Medtronic Lead Recall

MEDTRONIC LEAD RECALL October 2007 – After 5 reported deaths, Medtronic, Inc. suspended production and sale of its SPRINT FIDELIS defibrillator leads and requested return of all existing product from the hospitals and clinics worldwide. Since its introduction in 2004 over 250,000 SPRINT FIDELIS leads have been implanted in the U.S. providing the life saving links between a implanted defibrillator (ICD) and heart. The recalled leads are subject to cracks or fractures which “can cause the defibrillator to deliver unnecessary shocks or not operate at all” according to FDA director, Daniel Schultz.

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Defibrillator Lead Facts

  • Recalled Model Numbers begin with 6930, 6931, 6948, and 6949
  • Lead wires connect defibrillator to heart
  • Lead wires are the only way life saving therapy travels from the defibrillator to the heart
  • Cracked or fractured wires may deliver inappropriate shocks
  • Cracked or fractured wires may not deliver any shock when needed
  • Studies have shown that when operating and connected properly defibrillators (ICD) are highly effective in stopping deadly heart rhythm disorders especially in high risk patients
  • Patients and their Doctors may receive warning letters