FDA Deems Latest Abbott HeartMate Recall the Most Serious Yet

In another alarming development for patients relying on mechanical heart support, the FDA has classified the recall of Abbott’s HeartMate Mobile Power Unit (MPU) as a Class I recall—the most serious type—indicating that continued use of the product could result in serious injury or death.

What Is the Abbott HeartMate Mobile Power Unit?

The HeartMate MPU is an essential component of Abbott’s HeartMate II and HeartMate 3 Left Ventricular Assist Devices (LVADs), which help circulate blood for patients with advanced heart failure. The MPU provides power to the system controller, which monitors and controls the pump. These devices are commonly used at home or in clinical settings where constant monitoring isn’t required.

Details of the Recall

In April 2025, Abbott issued an urgent medical device recall after reports of serious power failures in its HeartMate MPUs. According to the FDA, the MPU may:

• Fail to turn on

• Shut down without warning

• Restart unexpectedly

In affected devices, users may see a “Yellow Wrench” or “No External Power” alarm from the system controller. Abbott traced the problem to a faulty electrical component in MPUs distributed between April 2024 and February 2025.

Although no serious injuries or deaths have been reported to date, the implications are grave. If the power unit fails and the system controller isn’t connected to backup batteries within 15 minutes, the pump will stop, risking thromboembolism, hemodynamic collapse, or death.

Scope and Timeline

Abbott reports that approximately 4,800 units worldwide may be affected. The company is currently replacing MPUs with known power issues and plans to proactively replace other impacted units starting June 2025 or sooner.

The FDA has directed the removal of certain units from use or sale due to the high risk of adverse health consequences.

KBD Attorneys Has Been Following HeartMate Recalls Closely

This latest recall follows several others involving the HeartMate line of devices. Just last year, the FDA classified multiple HeartMate system issues as Class I recalls, including those related to the HeartMate Touch Communication System and earlier versions of the LVADs.

We previously published a detailed article—Latest Abbott HeartMate System Recall And What It Means For Patients—to raise awareness about the dangers associated with HeartMate devices and to help affected patients understand their rights.

At KBD Attorneys, we have significant experience handling defective medical device lawsuits, including litigation involving cardiac assist devices and implanted medical technologies. We are actively investigating claims involving patients injured or endangered by HeartMate II and HeartMate 3 devices.

Legal Rights and Options for Patients

If you or a loved one uses a HeartMate II or HeartMate 3 LVAD and have been affected by this recall, you may be entitled to financial compensation. Our firm investigates claims involving:

• Product defects

• Failure to warn

• Negligence by manufacturers

Due to the FDA’s rigorous premarket approval process, claims involving medical devices may face federal preemption defenses. However, KBD Attorneys has the experience necessary to navigate these complex legal issues.

We’ve helped thousands of clients nationwide in defective product cases and are committed to holding negligent medical device manufacturers accountable.

For more information, review our additional resources:

• Heart Devices Lawsuit Information

• More News About the HeartMate II and HeartMate 3 Recalls

• FDA Recall: HeartMate 3

Talk to a Defective Medical Device Lawyer Today

We understand the fear and uncertainty patients face after a major medical device recall. That’s why KBD Attorneys offers free consultations to anyone affected by the Abbott HeartMate MPU recall or other serious device failures.

Fill our our online contact form to learn more about your legal options.

Let our experience be your advantage.