HeartMate 3 recalled due to risk of blood leaks or air in the system

Hundreds of HeartMate 3 left ventricular assist device (LVAD) systems are being recalled due to reports of blood leakage or air entering the sealing interface between the device's inflow cannula and the apical cuff, which has resulted in several deaths. I remember it was classified by the US Food and Drug Administration (FDA) as a class, the most serious type.

The newer generation HeartMate 3 is used to support adults and children with severe left ventricular heart failure. Abbott/Thoratec Corporation is recalling 882 of the devices following the reports. According to the FDA, all 81 cases involved blood leaks and air ingress during implantation of the devices. Injuries were reported in 70 cases and deaths in two cases.

“If blood leaks or air enters the LVAD from this location, it compromises the integrity of blood flow and may result in a longer-than-expected operation, hemorrhage (hemorrhage), right heart failure, or air embolism,” the agency noted.

The recall notice states that if blood leakage or air infiltration is suspected or observed, air must be completely evacuated from the device's blood chamber before LVAD support is initiated. Additionally, bleeding should be assessed and hemostasis properly managed before all wounds are closed. Conventional strategies to address air leaks or bleeding include: Adjusting the pump position, waiting for the blood's natural tendency to clot or reversing anticoagulation, adding surgical materials, and replacing the apical cuff, pump, or both.

“Always have a complete backup system (implant kit and external components) on site and in close proximity during the implantation procedure for use in an emergency,” Abbott/Thoratec advised in an urgent medical device correction notification letter, which was released on March 20, 2024.