Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00196-1
Product Name/Description	HeartMate 3 LVAS Kits Model Number: 106524INT ARTG 300895 (Abbott Medical Australia Pty Ltd - HeartMate 3 LVAS Implant Kit Model 106524INT - Implantable ventricular circulatory assist system)
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	20/03/2024
Responsible Entity	Abbott Medical Australia Pty Ltd
Reason/Issue	Abbott is notifying customers that 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. Potential harms due to this problem are extended surgery time, bleeding, haemorrhage, right heart failure, air embolism, or potential death from haemorrhage or air embolism.
Recall Action	Product Defect Correction
Recall Action Instructions	Abbott is providing a letter to customers reiterating content from the instructions for use (IFU) related to this issue and the management of. Abbott is also developing and qualifying a change in the seal interface to address this issue.
Contact Information	1800 839 259 – Abbott Medical