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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 administrationAdverse event reporting programHeartmate touch systemHeartmate controllerVentricular assist deviceHeartmate touch communication systemRecall database entryVentricular assistHeartmate systemHeartmate touchUse chapterMate touch communication systemHeartmate system controllerWireless adapterPower moduleAbbott technical support