Mobile Power Unit AC Power Cord Recall: Abbott Medical Removes AC Power Cord Associated with HeartMate Mobile Power Unit (MPU) Due to Potential Risk of the Cord Not Locking into Place

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 Name: AC Power Cord (model: 107760) for the HeartMate Mobile Power Unit (model: 107754)
Affected AC Power Cord Lot Numbers: 10763925, 10770095, 10794158, 10794159, 10794161, 10794162, 10794164, 10794166, 10794167, 10794170, 10794172, 10814683, 10814684, 10814685, 10831828

What to Do

On June 20, 2025, Abbott Medical sent Urgent Medical Device Recall notices to affected healthcare providers recommending the following actions:

Review the affected product list to identify potentially impacted power cords of the MPUs that are either on the shelves, used in the clinic, or already assigned to patients.
If the power cords and their associated MPUs are not listed as affected products, continued use of the MPUs and their associated power cords is acceptable.
If a clinic has patients with affected power cords, the following actions should be taken:
- Provide the patient the patient letter.
- Remind the patients to follow the instructions provided in the device Instructions for Use (IFU), as shown below. If the power cord does not lock into the MPU per the IFU, Abbott Technical Support should be contacted at 1-800-456-1477 for a replacement power cord.
  - Remind the patients to use the 14V batteries while they wait for the replacement power cord. Remind the patients that the Backup Battery in the System Controller must not be used as a power source during power failure as it will only temporarily power the pump for 15 minutes.
  - As a precaution, educate the patient to ensure the 14V batteries are ready and available for use.
  - Once the new power cord is provided, the patient should continue to use the MPU with the new power cord and return the defective power cord to Abbott.
Distribute this notice to those who need to be aware within the institution and to any organization to which these devices may have been transferred.
Abbott Representatives will visit impacted clinics and evaluate the MPU power cord inventory. Any power cords that are identified with this issue will be replaced through Abbott Technical Services.

The patient letter provided by Abbott Medical included the following recommendations:

Follow the HeartMate 3 Patient Handbook. If a new copy of the HeartMate 3 Patient Handbook is needed, contact the clinic or download it from the Abbott website at https://manuals.eifu.abbott/en/index.html.
Test the MPU power cord by pulling on it after it is fully inserted into the MPU. The yellow button should click into place when it is fully inserted. This will prevent the removal of the power cord unless the yellow button is pressed.
Contact the clinic or Abbott Technical Support at 1-800-456-1477 for a new power cord if the yellow button does not click into place and/or the power cord can easily be removed.
If the MPU loses power, confirm that the power cord is fully inserted. As long as the power cord is fully inserted, the MPU is safe to use while awaiting the new power cord.
Be reminded that the backup battery in the system controller can power the heart pump for up to 15 minutes. This safeguard allows time to switch from MPU to fully charged 14V batteries. Be reminded of the following:
- Every time the MPU is used for power, make sure the 14V rechargeable batteries are ready and available for use.
- If the yellow battery sign on the MPU is on, replace the AA batteries inside the MPU immediately. These batteries make the MPU alarms work.

Reason for Recall

Abbott Medical is recalling the power cord for the Mobile Power Unit (MPU), a power accessory of the HeartMate 3 Left Ventricular System (LVAS) and HeartMate II Left LVAS. Certain power cords distributed between May 6, 2025, and June 12, 2025, could not be securely locked into place in the MPU, and may be able to be pulled from the MPU without pressing the yellow V-Lock button on the female socket. The issue had been linked to the V-lock feature on some power cords being incorrectly positioned.

Although the affected MPUs are still able to receive power, the power cords are susceptible to unintended disconnection due to the inability to lock securely into place. If the power cord becomes disconnected during use, power will be lost from the MPU to the System Controller, which will trigger alarms on the System Controller and the MPU. If reconnection is not completed before the Controller Backup Battery is depleted in 15 minutes or if a System Controller exchange is unsuccessful, the pump flow will be lost.

Abbott is recommending removal of impacted cords but not recommending removal of the MPU from the field at this time because the issue is related solely to the cord and not the MPU itself.

The use of affected product may cause serious adverse health consequences, including hemodynamic instability (inadequate blood circulation), multi-organ failure, and death.

There have been no reported injuries or deaths related to this issue.

Device Use

The MPU is a power accessory of the HeartMate 3 LVAS and HeartMate II LVAS. It is for clinic or home use when the patient is indoors, stationary, or sleeping. It enables the blood pump to be powered by AC power from a wall outlet, instead of the HeartMate 14 Volt Lithium-Ion batteries. The MPU is connected to a wall outlet via a power cord. The MPU end of the power cord has a female socket, which is designed to connect and lock onto the MPU using a V-Lock mechanism.

Contact Information

Customers in the U.S. with questions about this recall should contact Abbott Technical Support at 1-800-456-1477.

Additional FDA Resources (listed in order of most to least recent):

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.

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