Chicago, Illinois – The U.S. Food and Drug Administration (FDA) has issued a Class I recall for nearly 14,000 HeartMate left ventricular assist devices (LVADs) manufactured by Abbott and its subsidiary Thoratec. This recall comes after continued concerns over safety that have been linked to multiple deaths associated with the devices.
The recall specifically pertains to the HeartMate II LVAD and HeartMate 3 LVAD, with the main issue being the gradual accumulation of biological materials within the devices over time. This buildup can impede the device’s function in aiding the heart in pumping blood effectively, leading to potential alarms of low blood flow and impacting the device’s overall performance. Such blockages have resulted in 14 deaths and 273 injuries thus far.
The FDA emphasizes the seriousness of using these affected LVADs, cautioning that the accumulation of biological material can have severe adverse health consequences and, in extreme cases, may lead to fatalities. The HeartMate 3 LVAD is notably approved for both short- and long-term treatment of patients with advanced heart failure, serving as a crucial device for this particular patient population in the U.S.
Medical professionals, including cardiologists and cardiac surgeons, rely on LVADs like the HeartMate 3 in various scenarios, from pre- and post-heart transplant procedures to permanent destination therapy when no other options are viable. The device operates by assisting the left ventricle in pumping blood, thereby supporting heart function and circulation throughout the body. Patients with severe heart conditions often depend on such devices for improved cardiac health and quality of life.