Abbott’s MPU is an accessory of its HeartMate II and HeartMate 3 left ventricular assist device (LVAD) systems. These systems feature an implantable pump diverting blood from the weakened left ventricle of the heart, pumping it to the aorta. The MPU powers the system controller, which controls and monitors pump and system operations. It’s for home or clinical use when the patient doesn’t require monitoring.
FDA’s notice said the recall involves removing certain devices from use or sale. Continued use of the MPU could lead to serious injury or death.
Abbott last month issued an urgent medical device recall notice after reports of sudden, unexpected performance issues with the MPU. The company reports zero serious injuries or deaths associated with the issue to date, though.
Reports included performance issues such as not turning on, unprompted shut down or suddenly turning off and restarting. In these cases, the system controller indicates a “Yellow Wrench” alarm or “No External Power Alarm.” Abbott determined that the issues relate to an electrical component used to manufacture MPUs distributed between April 2024 and February 2025.
The company plans to replace impacted MPU devices experiencing power issues immediately. It expects to begin replacing impacted MPU devices not currently experiencing power issues in June 2025 or earlier.
If an impacted MPU experiences a loss of power, the backup battery in the system controller can support the pump for up to 15 minutes. If the system controller isn’t connected to 14V rechargeable batteries within 15 minutes, the pump will lose power and stop. This could lead to serious adverse health consequences. Those include hemodynamic compromise (impaired blood flow and circulation), thromboembolism (blood clot blocking a blood vessel) or death.
This marks the latest recall-related issue for HeartMate in recent years. Last June, the FDA deemed another recall as serious, following Class I recalls of certain systems in both April and May.
