Abbott is notifying customers of a planned update to instructions for use associated with observed outflow graft deformation known as "extrinsic outflow graft obstruction" (EOGO) associated with the Heartmate 3™ left ventricular assist system (LVAS) and Heartmate II™ LVAS. Significant EOGO will manifest clinically as as a persistent low flow alarm under certain circumstances in some patients, and in such cases, may impair the ability of the Heartmate LVAS to provide adequate hemodynamic support. Recall start date: February 20, 2024
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