Recall of Sprint Fidelis Cardiac Leads

Added: Dec 13, 2007   By: USFoodandDrugAdmin

Duration: 1:47

Channel: News

Medtronic Inc. has stopped distributing Sprint Fidelis defibrillation leads because of the possibility that these leads could fracture in a small percentage of patients. Although the leads continue to function properly in the vast majority of patients, if one does fracture, the defibrillator could deliver unnecessary shocks or not operate at all. Some deaths and major complications have occurred when the leads fractured. The affected products are Sprint Fidelis Models 6930, 6931, 6948,...

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Tags: crt-d  defibrillator  fidelis  fracture  icd  implant  leads  medtronic  recall  sprint