Abbott HeartMate Mobile Power Unit Recalled Over Sudden Power Loss Risks

Officials warn that a loss of power in the HeartMate unit could result in serious injury or death if patients are unable to restore pump function within a critical 15-minute window.

Abbott is recalling certain HeartMate Mobile Power Units (MPU) used with the HeartMate 3 and HeartMate II Left Ventricular Assist Systems (LVAS), after the devices were found to suddenly lose power without warning.

The HeartMate Left Ventricular Assist Systems (LVAS) are implantable medical devices designed to assist patients suffering from advanced left ventricular heart failure by helping circulate blood throughout the body. The system includes an implanted heart pump, which is controlled and monitored by an external System Controller. To power the System Controller when patients are away from stationary power sources, a portable accessory called the HeartMate Mobile Power Unit (MPU) is used, allowing patients to remain mobile while maintaining continuous pump function.

However, officials are warning that an electrical component may fail without warning, causing the Mobile Power Unit to suddenly shut down or lose power. Since these mobile units are often used outside of hospital settings, unexpected shutdowns pose a critical risk for patients who may not be able to quickly switch to an alternative power source.

HeartMate Recalls and Problems

Since the FDA first approved the HeartMate device in 2001, concerns about the safety and reliability of the systems have steadily escalated following a series of HeartMate recalls and safety warnings.

In May 2024, Abbott recalled certain HeartMate 3 systems after reports of blood leaks and air embolisms, which increased the risk of hemorrhaging, stroke and heart failure. Leaks in the inflow cannula were found to compromise the device’s ability to circulate blood properly, often requiring emergency surgery. The agency indicates the manufacturer has become aware of at least 81 incidents of blood leaks or air entering the devices, resulting in 70 injuries and two deaths linked to the HeartMate 3.

In years prior, the HeartMate II and HeartMate 3 accessories have been implicated in several other recalls over battery backup failures, controller communication errors, and biological material buildup, which have been linked to hundreds of HeartMate LVAS obstruction problems and at least 14 deaths.

2025 Abbott HeartMate Recall

In the latest HeartMate recall announced by the U.S. Food and Drug Administration on April 24, Abbott indicates that certain HeartMate Mobile Power Units used with the HeartMate 3 Left Ventricular Assist System (LVAS) and HeartMate II LVAS may suddenly lose power, posing a serious risk for patients who rely on continuous circulatory support due to severe heart failure.

The recall was initiated after reports surfaced of MPUs suddenly shutting down, failing to turn on, or restarting unexpectedly during use. In many cases, these failures triggered system controller alarms, such as a flashing Yellow Wrench symbol or a “No External Power” warning.

Abbott indicates that if an MPU fails, the System Controller’s Backup Battery can temporarily power the heart pump, but only for up to 15 minutes. If patients do not switch to fully charged 14V rechargeable batteries during that window, the pump will lose power and stop.

The FDA recall notice warns that this could lead to hemodynamic compromise, thromboembolism, severe circulatory failure or death. Although Abbott has not reported any deaths or serious injuries linked to these MPU failures, the company is urging immediate action to prevent life-threatening events.

The affected MPUs can be identified by the Unique Device Identifier (UDI-DI: 05415067038234) and specific serial numbers distributed between April 2024 and February 2025. Abbott has provided a product lookup tool for healthcare providers and patients to verify whether a device is impacted.

Abbott first sent an Urgent Medical Device Recall notice to healthcare providers in early March, directing providers to review affected serial numbers to identify impacted MPUs and notify any patients who received an affected unit. Patients using MPUs with known power issues should be immediately switched to 14V rechargeable batteries, and the faulty units should be replaced.

For devices not currently showing problems, healthcare providers were instructed to educate patients about emergency backup procedures, ensure backup batteries are readily available, and return any impacted MPUs still in clinic inventory to Abbott for replacement. Patients assigned a recalled MPU should confirm their serial number using Abbott’s lookup tool, keep 14V rechargeable batteries on hand, be prepared to switch power sources immediately if alarms activate, and contact their provider or Abbott if affected.

Patients and healthcare providers with questions about the HeartMate MPU recall can contact Abbott Customer Support at 1-800-456-1477. Any adverse reactions or quality problems should also be reported to the FDA’s MedWatch Adverse Event Reporting Program.

HeartMate Recall Lawsuits

Given the growing number of HeartMate problems dating back to 2011, lawyers are reviewing potential HeartMate lawsuits for those who have suffered injuries or for families of individuals who have suffered a wrongful death caused by problems with the HeartMate devices.

To determine if you or a loved one may be eligible for a HeartMate recall lawsuit, submit information about your potential claim for a HeartMate recall lawyer to review.