HeartMate 3™ Left Ventricular Assist System: Class I Recall – Due to Potential Malfunction that may Lead to Graft Occlusion
The class I recall is due to a malfunction in the device’s outflow graft assembly that may cause the outflow graft to twist and close up (occlusion) over time. Occlusion of the outflow graft can reduce or stop pump flow and set off a persistent low flow alarm in the system. A reduction in pump can lead to serious adverse events such as blood clots and death.
• Recalled Products: HeartMate 3™ Left Ventricular Assist System
• Model/Item Numbers: Catalog # 106524US (U.S. commercial), 106524 (U.S. Investigational Device Exemption number), 10652INT (international)
• Lot Numbers: All lots
• Manufacturing Dates: All
• Distribution Dates: September 2, 2014 to present
• Devices Recalled in the U.S.: 4,878 units nationwide
BACKGROUND: The HeartMate 3™ Left Ventricular Assist System helps deliver blood from the heart to the rest of the body. It is used for short-term support of patients who are at risk of death from end-stage left ventricular heart failure, such as patients awaiting a heart transplant. The system includes a blood pump that is implanted in the space around the heart (pericardium) along with an outflow graft that connects the pump to the aorta.
RECOMMENDATION: Patients experiencing a persistent low flow alarm should contact the physician managing their HeartMate 3™ Left Ventricular Assist System immediately. Abbott is recommending not to remove the device because of this issue.
Read the FDA Alert