J&J recalls certain heart pump controllers due to hardware issues
The U.S. Food and Drug Administration (FDA) has detailed a new Class I recall for certain Automated Impella Controllers (AICs) from Johnson & Johnson MedTech. The devices require multiple hardware updates and then they can be used again to treat patients.
Four specific issues are at the heart of this recall:
- There is a risk of electrostatic discharge that could “interrupt motor controls.”
- There is a risk of a memory card becoming dislodged.
- There is a risk of fan wire damage.
- There is a risk of “potential capacitor-related issues” that could lead to different devices failures.
A majority of AIC units have already received the necessary hardware updates to correct these issues. However, 91 units are still on the market that still need to be fixed.
Care teams can continue using these devices for now. However, the company will be reaching out to schedule a return so that the updates can be performed.
Click here for more details from the FDA.
Another recall for the Impella platform
Johnson & Johnson MedTech’s Impella devices have 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.
In addition, the FDA just shared an additional alert about the AICs on May 21. The software error at the center of that alert is still under investigation.
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.