Health Canada — Medical Devices · Canada · 2024-04-05 · Type I
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Reported risk: There have been complaints of blood leaking out of the left ventricle or air entering the left ventricle or Left Ventricle Assist Device (LVAD) which are attributed to a leak path at the seal interface between the Heartmate 3 Left Ventricle Assist System (LVAS) inflow cannula and the titanium apical cuff. The blood leak or air entrainment has only been observed during the implantation procedure. Once the bleeding or air entrainment was resolved intraoperatively, the issue did not re-occur postoperatively. Abbott's investigation determined that in certain instances, routine manipulation of the pump or internal fluid pressures during implantation can result in a compressed sealing ring on one side, leading to a leak path on the opposite side. Recall Start Date: March 19, 2024
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