The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories. The devices are not currently being removed from the market.
It is the first LVAD trial to examine five-year outcomes and surpasses a previous Abbott study on HeartMate 3, which recorded a survival time of two years. The device was found to reduce morbidity and mortality, largely because of fewer deaths by stroke, clotting and bleeding.
Patient expectations continue to evolve, and healthcare practices that fail to adapt risk more than just revenue—they risk losing trust.