FDA announces recall of all Impella heart pump controllers after 3 deaths
The U.S. Food and Drug Administration (FDA) has warned the public that all Johnson & Johnson MedTech Automated Impella Controllers (AICs) should be removed from where they are used and sold.
This is a global device removal that may take some time. Clinicians can continue to use these devices as they await a replacement.
This recall covers three products in total:
- Impella Controller, Packaged – 0042-0000-US
- Impella Optical Controller, Packaged – 0042-000010-US
- Optical, AIC, Impella Controller, Packaged – 0042-0040-US
Key details about this Impella issue
This alert is due to ongoing issues with purge cassette recognition that have been associated with a total of 37 serious injuries and three deaths. When this occurs, it starts with the purge flag component within the AIC’s pure pressure sensor assembly. Johnson & Johnson MedTech and the FDA have provided instructions for users who experience such an issue while waiting for their replacement AIC.
If that purge flag component fails as a procedure is being set up, it sets off a “Purge Disc Disconnected” alarm that can be addressed by reinserting the purge disc. When that does not stop the alarm, the user should then move on to a backup AIC. On the other hand, if that purge flag component fails while hemodynamic support is being provided, it sets off a “Purge Disc Not Detected” alarm that can be addressed in the same way. Again, if that does not correct the problem, the user should use a backup AIC instead. Finally, if the purge flag component fails during active Impella support, the heart pump should still work as intended as the care team prepares to exchange the AIC.
Click here for more details from the FDA. The agency is still reviewing the situation at this time. This early alert is part of a new FDA program designed to keep the public informed about any potential issues right away.
The “Purge Disc Disconnected” alarm. Image courtesy of Johnson & Johnson MedTech and the FDA.
Johnson & Johnson shares a statement
“Johnson & Johnson has issued a voluntary recall of Automated Impella Controllers to address a purge cassette recognition issue identified in 0.2% of cases,” a company spokesperson told Cardiovascular Business. “Hospital inventory can continue to be used to ensure continuity of care. Patient safety remains our top priority, and existing alarms and monitoring support the safe and effective use of Impella.”
Another recall for the Impella platform
Johnson & Johnson MedTech’s Impella devices have been associated with multiple recalls and safety alerts in recent years. In the last several months alone, AIC issues were linked to one recall in July 2025, a second recall in September 2025, third and fourth recalls in October 2025, a fifth recall in December 2025 and a sixth recall in May.
In April, the FDA announced a separate recall related to a risk of purge cassettes leaking. Approximately two months later, the agency warned that certain 14 French low-profile introducer kits were recalled due to a risk of thrombus formation. And in early August, certain introducer sheaths used with Impella devices were recalled due to a risk of leaking.
Johnson & Johnson acquired Abiomed in 2022
The Impella line of heart pumps was 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.