HeartMate 3™ Left Ventricular Assist System Kits – Blood leak or air entrainment at inflow O ring and apical cuff interface

A Dear Healthcare Professional Letter has been issued by Abbott Medical (Singapore) to inform healthcare professionals of a potential leak path at the seal interface between the HeartMate 3™ Left Ventricle Assist System (LVAS) inflow cannula and the titanium apical cuff, resulting in bleeding or air entrainment during implantation. This issue has only been observed during the implantation procedure, where routine manipulation of the pump or internal fluid pressures can result in a compressed sealing ring on one side and a leak path on the opposite side. Blood leakage or air entrainment may lead to the following while the integrity of the blood pathway is being restored by the surgeon: extended surgery time, bleeding, haemorrhage, right heart failure, air embolism, or potential death from haemorrhage or air embolism. Abbott is currently developing and qualifying a change in the seal interface to address this issue. Healthcare professionals are advised to refer to recommendations within the letter on how to resolve suspected or observed blood leakage or air entrainment during surgery. Please refer to the letter for details.

Published: 4 Apr 2024

Dear Healthcare Professional Letters