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  • Aug 27, 2025

    FDA details new risk with Johnson & Johnson heart pump controllers after patient’s death

    Cardiovascular Business

    warning safety alert recall healthcare issue

    The U.S. Food and Drug Administration (FDA) is warning the public about a new safety issue associated with Johnson & Johnson MedTech’s Automated Impella Controller (AIC). 

    This latest alert was put in place after Johnson & Johnson MedTech received reports that some of the Pump Driver Circuit Assemblies of its AICs contain 25V-rated tantalum capacitors instead of the expected 35V-related tantalum capacitors. This can 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. 

    Affected devices should not be used

    This alert covers a total of 69 AICs. Full lists of the affected product codes and serial numbers are available as part of the FDA’s advisory. Anyone with one of the affected devices is urged not to use it any longer. Instead, the device should be quarantined until additional information is made available.

    “The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available,” according to the advisory.

    Johnson & Johnson MedTech Automated Impella Controller

    Johnson & Johnson MedTech’s Automated Impella Controller. Image courtesy of Johnson & Johnson MedTech.

    FDA’s warning comes less than two months after a similar alert

    In early July, the FDA sent out a similar alert about certain AICs due to reports of the device not properly connecting with the Impella heart pumps. The issue was linked to three patient deaths.

    Weeks later, the FDA came forward and said the AIC issue had officially been classified a Class I recall. More than 11,000 units distributed all over the world were included in the recall. It was not a product removal, however.

    “The AIC and Impella pumps remain on the market and available for patient care,” Johnson & Johnson MedTech told Cardiovascular Business at the time. “Educating healthcare professionals about recommended practices to improve outcomes for patients remains a priority, and we are dedicated to the mission of providing safe and effective life supporting technology to patients worldwide.”

    Johnson & Johnson MedTech shares a statement

    Johnson & Johnson MedTech shared a statement with Cardiovascular Business emphasizing the fact that this issue covers a total of 69 AICs around the world. 

    "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 the company's 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. Following the sale, the company began operating under the name Johnson & Johnson MedTech.

    Related Impella Content:

    FDA announces Class I recall due to heart pump controller issue
    FDA shares warning after Johnson & Johnson heart pump controllers linked to 3 deaths
    FDA announces new recall of Johnson & Johnson heart pumps over safety concerns
    Johnson & Johnson to acquire Abiomed in $16.6B deal
    Michael Walter
    Michael Walter, Managing Editor

    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.

    Read original article here: https://cardiovascularbusiness.com/topics/clinical/interventional-cardiology/fda-details-new-risk-johnson-johnson-heart-pump-controllers-after-patients-death?utm_source=newsletter&utm_medium=cvb_heartfailure

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