Heart Pump Accessory Removal: Abbott Removes HeartMate Mobile Power Unit due to Instances of Sudden Power Loss

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.

Affected Product

• Product Names: HeartMate Mobile Power Unit (MPU) used with the HeartMate 3 Left Ventricular Assist System (LVAS) and HeartMate II LVAS
• Unique Device Identifier (UDI)/Model: UDI-DI: 05415067038234
• Affected Reference and Serial numbers [XSLX 34.2KB]
• Abbott also provides a product lookup tool to check if specific MPU serial numbers are affected by this issue.

What to Do

Do not use MPUs experiencing performance issues such as sudden loss of power and the visual/audio alarms shown in Table 1. Patients should be immediately switched to the 14V rechargeable batteries. If the batteries are not connected to the System Controller within 15 minutes of MPU power loss, the System Controller Backup Battery will deplete, causing pump power loss.

On March 13, 2025, Abbott sent all affected health care providers an Urgent Medical Device Recall notice recommending the following actions:

• Actions for Health Care Providers
  • Review the affected serial numbers list (see above) to identify impacted devices and patients.
    • If you are able to identify patients that have been assigned MPUs using the serial number list, please send those patients the patient letter provided by Abbott (see Additional Company Resources section below).
    • If you are not able to identify patients that have been assigned MPUs using the serial number list, please send all patients that have received an MPU from April 2024 to March 2025, the patient letter provided by Abbott (see Additional Company Resources section below).
  • For units that patients are currently using and have experienced MPU power issues, transfer the patient from the MPU to the 14V rechargeable batteries within 15 minutes. The Backup Battery in the System Controller will temporarily power the pump during a power source switch. Do not rely only on the System Controller’s Backup Battery as a power source during power failure, as it will only power the pump for up to 15 minutes. Do not continue to use the MPU and immediately contact Abbott for a replacement.
  • For units currently used by patients, but not experiencing MPU power issues, educate impacted patients about the issue. Ensure the patient’s 14V rechargeable batteries are ready and available for use at any time and remind the patient to replace AA batteries inside the MPU immediately if the Yellow Mobile Power Unit Battery Indicator alarm is active. The internal AA batteries ensure that the MPU echoes the System Controller Alarms.
  • For impacted MPU units that are currently in your clinic and have not yet been provided to a patient for use, immediately return them to Abbott for a replacement.
• Actions for Patients and Users
  • Confirm if your MPU serial number is affected (see above).
  • If your serial number is listed, make sure your 14V rechargeable batteries are ready and available for use every time you use the MPU for power.
  • If sudden power loss of your MPU occurs or your MPU suddenly shuts down and restarts, you must switch from the MPU to the fully charged 14V rechargeable batteries within these 15 minutes. Otherwise, your pump will stop.
  • If your MPU serial number is not listed, this issue does not apply to your MPU. 

Reason for Removal

Abbott has received reported incidents in which the MPU experienced sudden, unexpected performance issues such as not turning on, unprompted shut down, or suddenly turning off and restarting, with the System Controller indicating a Yellow Wrench alarm or “No External Power” alarm. Abbott has identified that these issues are linked to an electrical component used to manufacture certain MPUs distributed between April 2024 and February 2025. Replacement of impacted MPU devices that have experienced power issues will begin immediately; replacement of impacted MPU devices not currently experiencing power issues will begin 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 14V rechargeable batteries are not connected to the System Controller within 15 minutes, the pump will lose power and stop. This could lead to serious adverse health consequences such as hemodynamic compromise (impaired blood flow and circulation), thromboembolism (blood clot blocking a blood vessel), or death.

Abbott has not reported any serious injuries or death associated with this issue.

Device Use

The Mobile Power Unit (MPU) is an accessory of the HeartMate II and HeartMate 3 Left Ventricular Assist Systems. These systems also include a Left Ventricular Assist Devices (LVAD), an implantable pump diverting blood from the weakened left ventricle of the heart and pumping it to the aorta, and a System Controller, which is a small computer that controls and monitors pump and system operations. The MPU powers the System Controller and is for home or clinical use when the patient does not require monitoring.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact the Abbott at 1-800-456-1477.

Additional Company Resources

Company-provided information is posted here by the FDA as a public service.

1. Abbott Product Advisories
2. Abbott product lookup tool
3. Customer Letter – HeartMate MPU (March 2025)
4. Patient Letter – HeartMate MPU (English) (March 2025)
5. Patient Letter – HeartMate MPU (Spanish) (March 2025)

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.