FDA confirms Class I recall for certain Impella heart pump controllers
The U.S. Food and Drug Administration (FDA) has shared an update about an alert the agency first published in September about certain Automated Impella Controllers (AICs) from Johnson & Johnson MedTech.
At the time, the FDA said these devices should be removed from where they are used or sold, but it was still investigating the issue to learn more. Now, with its investigation complete, the agency has officially ruled that this is a Class I recall, which means using the devices could cause “serious adverse health consequences or death.”
The reason for this Class I recall
This alert was originally put in place after Johnson & Johnson MedTech found that certain AICs require hardware, firmware and/or software updates to address various safety concerns. There is a chance of the AIC failing to recognize the purge cassette during setup, for instance, and a “sticking, unreliable button” could make it harder for the operator to use some devices during patient care.
No serious injuries or deaths have been linked to these issues, but Johnson & Johnson MedTech decided to act fast to minimize any potential risks.
What customers need to know
This Class I recall only covers specific lots of the following devices:
- Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump – 428 units.
- Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump – 179 units.
- Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump – 293 units.
These devices should be removed from where they are used or sold until they can be serviced. If absolutely necessary to ensure a patient receives care, however, they can still them.
Click here for more details from the FDA.
Johnson & Johnson comments on the alert
Johnson & Johnson provided a statement when this issue was first announced. The company confirmed to Cardiovascular Business that the same statement has not changed.
“Our commitment to quality, safety, and reliability is the foundation of everything we do at Johnson & Johnson,” the company said at the time. “Working closely with the FDA, we conducted retrospective reviews to implement quality system improvements for AIC. This includes a voluntary medical device recall of certain AICs after identifying some units require specific hardware and/or software updates.
“To ensure continuity of care, with existing alarms, monitoring and mitigation actions, hospital inventory can continue to be used as we work directly with affected customers to implement the necessary updates.”
Reviewing recent Impella recalls
Johnson & Johnson MedTech’s Impella devices have been associated with multiple recalls and safety alerts in recent years. For example, 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 a sixth recall in May and a seventh recall in August and an eighth recall in September.
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.