Left Ventricular Assist System (LVAS) Monitor Correction: Abbott Issues Correction for HeartMate LVAS System Monitor due to Screen Issues that May Cause Unintentional Pump Stop

Abbott Medical is recalling the HeartMate System Monitor, part of HeartMate LVAS systems, due to atypical behavior of the System Monitor screen (screen issues). The System Monitor is only used in the operating room or during clinic visits. The screen issues include screen freezing, overlapping buttons or screens, unresponsive buttons, distorted text or graphics, and wrong or missing information on the display. These issues can cause a clinician user to inadvertently change pump settings or press the pump stop button.

This recall involves correcting devices and does not involve removing them from where they are used or sold. The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. This device may cause serious injury or death if you continue to use it without correction.

Questions?

Customers in the U.S. with questions about this recall should contact their local firm representative or Abbott Medical Technical Support at 1-800-456-1477.