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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. ....

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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. ....

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