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FDA Announces Abbott Recall of HeartMate Touch Communication System for Unintentional Pump Start and Stop

The U.S. Food and Drug Administration (FDA) announced that Abbott is recalling its HeartMate Touch System (version 1.0.32) for risk of unexpected pump stop or start. Issues may occur if the HeartMate Touch System is disconnected from a patient’s HeartMate Controller while a “pump stop” command is running. People who have the implantable HeartMate 3 Left Ventricular Assist Device may be affected.
Drug Administration Adverse Event Reporting Program Heartmate Touch System Heartmate Controller Ventricular Assist Device Heartmate Touch Communication System

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