The U.S. Food and Drug Administration (FDA) announced on June 28 that Abbott Medical has issued a correction for the HeartMate Left Ventricular Assist System (LVAS) Monitor due to screen issues that may cause unintentional pump stop.

Screen issues exhibited by the HeartMate LVAS Monitor include screen freezing, overlapping buttons or screens, unresponsive buttons, distorted text or graphics, and wrong or missing information on the display. According to the agency, these issues may lead “a clinician user to inadvertently change pump settings or press the pump stop button.”

Abbott Medical’s correction includes information for what clinicians should do if screen issues are observed or in the case of pump stop. Access the FDA website to learn more.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Cardiac Surgery and Heart Failure, Acute Heart Failure, Mechanical Circulatory Support

Keywords: United States Food and Drug Administration, Heart-Assist Devices, Heart Failure