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HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion

Diverse Support Group Patient with Doctor
Wednesday, May 23, 2018

The class I recall is due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump can lead to serious adverse events such as blood clots and death.

Recalled Products: HeartMate 3™ Left Ventricular Assist System
Model/Item Numbers: Catalog # 106524US (U.S. commercial), 106524 (U.S. Investigational Device Exemption number), 10652INT (international)
Lot Numbers: All lots
Manufacturing Dates: All
Distribution Dates: September 2, 2014 to present
Devices Recalled in the U.S.: 4,878 units nationwide