Heart of Health Policy | FDA Update: Class I Recall for HeartMate 3 Left Ventricular Assist System
The U.S. Food and Drug Administration recently issued a Class I Recall for the HeartMate 3™ Left Ventricular Assist System due to a malfunction that may lead to graft occlusion.
The potential defect in the device’s outflow graft assembly may cause the graft to reduce or stop pump flow, setting off a low flow alarm. Reduced pump flow can lead to serious adverse events including blood clots or death. Recalled products were distributed from Sept. 2, 2014, to present, totaling 4,878 recalled products nationwide. Affected devices include model numbers 106524US, 106524 and 10652INT.
Keywords: ACC Publications, Cardiology Magazine, Health Policy, United States Food and Drug Administration, Medical Device Recalls, Thrombosis, Product Recalls and Withdrawals, Vascular Diseases
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