FDA announces new recall of Abbott heart pump accessories over significant safety risks
The U.S. Food and Drug Administration (FDA) has announced that Abbott is recalling the mobile power units (MPUs) associated with some of its HeartMate left ventricular assist devices (LVADs).
This recall covers certain MPUs used with both the HeartMate 3 LVAD and HeartMate II LVAD. It has been identified as a Class I recall, the FDA’s most serious classification, and using the devices “may cause serious injury or death.”
The reason behind the new mobile power unit recall
Abbott has received reports that the MPUs are experiencing “sudden, unexpected performance issues” that include suddenly turning on, turning off or restarting. When these issues occur, a “Yellow Wrench” or “No External Power” alarm becoming visible on the device’s system controller.
“Abbott has identified that these issues are linked to an electrical component used to manufacture certain MPUs distributed between April 2024 and February 2025,” according to a new advisory now posted on the FDA’s website. “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.”
According to Abbott, the system’s backup battery can provide device support for up to 15 minutes. If 14V rechargeable batteries are not connected to the system controller within 15 minutes, the pump will then loser power and stop working altogether.
“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,” according to the advisory.
There have been no reports of serious injuries or deaths as of April 25.
HeartMate 3 LVAD image courtesy of Abbott.
Next steps for healthcare providers impacted by the recall
Abbott sent out an Urgent Medical Device Recall notice to all healthcare providers who may be impacted by this recall back in March.
Providers were asked to send a letter from Abbott to all patients who have already received a mobile power unit included in the alert. If it cannot be determined which patients did and did not receive a device included in the recall, on the other hand, all patients who received a mobile power unit from April 2024 to March 2025 should be sent the letter.
If issues start to occur with a patient’s MPU, meanwhile, Abbott should be contacted immediately for a replacement.
Any unused MPU units should not be given to any patients; Abbott wants them returned right away and will supply a replacement.
Abbott has posted a link that can help healthcare providers determine whether or not their devices are impacted by this recall.
Image courtesy of Abbott.
A recent history of recalls for HeartMate devices
The Abbott devices have been at the heart of multiple FDA recalls over the last two years. In April 2024, for instance, customers were warned that the buildup of biological materials can cause issues. Instead of calling for the LVADs to be returned, the FDA urged customers to pay close attention to low-flow alarms.
The FDA then announced a separate Class I recall in May 2024 after receiving multiple reports of blood or air entering the device during implantation. There was no call for the devices to be returned—instead, the FDA and Abbott emphasized the importance of following certain steps to avoid such issues.
Another Class I recall was announced in June 2024. Again, this was a product correction and not a full removal. Abbott shared recommendations for customers to help them avoid any issues going forward.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.