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Abbott reports more HeartMate LVAD problems

Abbott's problems with its HeartMate LVADs continue to grow, this time involving system monitors.

FDA Announces Recall of Heart Device Warning of 'Serious Injuries or Death'

Abbott Recalls HeartMate Touch System

The HeartMate Touch Communication System (version 1.0.32) is being recalled because the pump may unexpectedly stop or start.

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.

Recall of Abbott HeartMate comms system is Class I

The FDA deemed a recall of the Abbott (NYSE:ABT) HeartMate Touch Communication System Class I, the most serious kind of recall.