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Class I recall of defibrillator leads: A comparison of the Sprint Fidelis and Riata families
Heart Rhythm, 08/08/2012
Liu J et al. – In this study, a comparative analysis of the failure–free survival of 2 recalled leads demonstrates discrepancies in the timing of the recall despite comparable failure–free survival patterns leading to the recall. The causes of these discrepancies are unclear and raise questions regarding the consistency of postmarketing surveillance and manufacturers' reporting of malfunctions of medical devices.