FDA warns public about Johnson & Johnson heart pump controllers after patient death
The U.S. Food and Drug Administration (FDA) is warning the public about a new safety concern with Johnson & Johnson MedTech’s Automated Impella Controllers (AICs). The issue has been linked to two serious injuries and one patient death.
At this time, no devices need to be returned to the manufacturer. The FDA said it is just sharing information about the issue to minimize any risks going forward.
The reason for this early alert
Johnson & Johnson MedTech found that AIC may restart due to a software error when used with a left ventricular Impella device. The risk occurs after at least 80 minutes of no residual pulsatility.
“During the restart, the AIC screen will turn black without further alert and the pump will stop for a duration of approximately 35 seconds based on preliminary data, during which the patient is unsupported by the Impella system and regurgitation via the cannula may occur.,” according to the alert. “After the AIC restarts, the pump will automatically resume at the previous P-level. Replacement of the AIC with another AIC would not resolve the potential for an AIC restart.”
If patients do not have alternative mechanical support in place, they would then face a risk of serious injury or death “due to the resulting lack of hemodynamic support.”
What healthcare providers need to know
At this time, the AICs can still be used like normal. No devices need to be returned to the manufacturer. Johnson & Johnson MedTech is actively working on a software update that will address the issue.
In the meantime, all customers impacted by this alert have been sent with instructions on how to respond if an unexpected system reboot occurs. The FDA’s advisory emphasized that a console exchange is not necessary if this situation unfolds, because the same thing will happen with the newer console.
Click here for more details from the FDA. At this time, the agency is still reviewing details and has not yet determined the severity of the recall. This early alert is part of a new FDA policy designed to keep the public informed about any potential issues right away.
Another recall for Automated Impella Controllers
Johnson & Johnson MedTech’s Impella platform has been associated with a significant number of recalls and safety alerts. In the last several months alone, AIC issues were linked to one recall in July 2025, a second recall in September 2025, a third and fourth recall in October 2025 and then a fifth recall in December 2025.
In April, meanwhile, the FDA announced a separate recall related to a risk of purge cassettes leaking.
Johnson & Johnson acquired Abiomed in 2022
The Impella line of heart pumps were previously sold under the Abiomed brand before Johnson & Johnson acquired Abiomed in 2022 for approximately $16.6 billion. In 2024, Abiomed started operating under the name Johnson & Johnson MedTech.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.