Safety concern with Johnson & Johnson heart pump controllers leads to Class I recall
The U.S. Food and Drug Administration (FDA) has classified an ongoing safety issue with Johnson & Johnson MedTech’s Automated Impella Controller (AIC) as a Class I recall. Class I recalls are the most serious category, highlighting the agency’s concern that these devices could “cause serious adverse health consequences or death.”
This recall was put in place after Johnson & Johnson MedTech received reports that some of the Pump Driver Circuit Assemblies found on its AICs contain 25V-rated tantalum capacitors instead of the expected 35V-related tantalum capacitors. This can potentially cause the pump’s performance to suffer, and there a risk of the pump stopping altogether and triggering an “Impella Failure” or “Impella Stopped. Controller Failure” alarm.
One patient death has been linked to this issue.
The FDA shared an early alert about this concern in August, but it was still reviewing the situation at the time.
What customers need to know
This recall includes a total of 69 AICs. A full list of affected serial numbers is available as a download on the FDA’s original early alert about this issue.
Johnson & Johnson MedTech’s Automated Impella Controller. Image courtesy of Johnson & Johnson MedTech.
The FDA’s Class I recall does indicate it covers more than 2,700 devices, but Johnson & Johnson MedTech told Cardiovascular Business this was an error. The company has requested that the FDA update this figure.
As the FDA emphasized in August, customers should not use any of these affected devices any longer. The devices should be quarantined immediately.
A statement from the manufacturer
Johnson & Johnson MedTech did share a statement with Cardiovascular Business when this issue was first announced to the public.
“A review of complaints from January 2011 to June 2025 showed a 0.006% occurrence rate, with one complaint reporting a patient death,” according to that statement. “Our first priority is our patients, and we are deeply committed to ensuring the safety and quality of our technologies. We notified impacted customers starting Aug. 21, 2025 and will provide loaner AICs for customer use.”
Johnson & Johnson acquired Abiomed in 2022
The Impella heart pumps and AIC technology 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.