Medtronic Recalls Sprint Fidelis Leads Due to Failures Causing Serious Injuries and Death

Recently, Medtronic, Inc., the manufacturer of Sprint Fidelis Leads, notified doctors that there is a chance that fractures may occur in particular locations on some of its leads (Models 6930, 6931, 6948, 6949) that have been implanted in patients. Sprint Fidelis Leads are cardiac electrodes that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. A fracture can cause the defibrillator to deliver unnecessary shock to the heart or to not operate at all. Some deaths and other serious injuries have been reported in which a fracture in a Sprint Fidelis Lead may have been a possible or likely contributing factor. As a result, Medtronic has voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads and has advised doctors to stop implanting them.

This recall does not affect patients who have Medtronic devices that are pacemakers, which keep the heart from going too slowly. It only affects patients who have the defibrillators, which keep the heart from going too fast. This recall also does not affect those patients who have Medtronic ICD or CRT-Ds without a Sprint Fidelis Lead.

If you or someone you know has a defibrillator with Sprint Fidelis Leads, you should first contact a physician, especially if the person has been experiencing multiple shocks, lightheadedness, fainting or palpitations. You should also check the patient identification card to confirm that the model number is one of the four model numbers implicated in the recall (6930, 6931, 3948, 6949).

If you or someone you know has had a Medtronic Sprint Fidelis Lead implanted that is one of the four model numbers that have been recalled, please use the form below to contact us.