The Food and Drug Administration (FDA) issued a class I recall of the HeartMate 3 left ventricular assist device on May 17.
The HeartMate 3 is an implanted heart pump that can help the heart deliver blood throughout the body. Patients with advanced heart failure may have left ventricular devices such as the HeartMate 3 implanted in place of a heart transplant or while waiting for a transplant.
Due to reports of outflow graft twist occlusions, the FDA has recalled over 4,800 units in the US. According to the FDA, there is a “malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time.” This occlusion may impede pump flow, which can ultimately lead to blood clots, death, and other adverse events.
The affected model numbers are 106524US, 106524, and 10652INT including all lot numbers and manufacturing dates distributed from September 2, 2014 to present, according to the FDA.
This recall follows an Important Medical Device Advisory letter sent by the FDA to HeartMate 3 physicians on April 5. The letter notified physicians of reports of complications with occlusion in the device and provided recommendations on managing patients with implanted HeartMate 3 devices. Physicians received an Urgent Medical Device Recall notification on May 21, which further detailed the device malfunction.
Patients with the device who have experienced a persistent low flow alarm have been recommended to contact their physician as soon as possible.