FDA confirms new recall for Johnson & Johnson heart device over safety concerns
The U.S. Food and Drug Administration (FDA) has finalized a new recall for Johnson & Johnson MedTech’s Automated Impella Controllers (AICs) due to potential connectivity issues. This is not a product removal, but all customers are urged to review the updated instructions.
The agency first sent out an early alert about these concerns in July, but it was still reviewing the available information at that time. Now, the FDA has confirmed that this is a Class I recall, which means using the device without following the new instructions could results in serious injuries or death.
In total, these connectivity issues have been linked to no serious injuries and three patient deaths.
The issue behind this recall
Johnson & Johnson MedTech has received reports of the AIC not detecting Impella heart pumps when they are connected. If the connection fails without the user noticing immediately, the FDA said it “may result in inadequate hemodynamic support.”
“Patients in cardiogenic shock are at increased risk, as prolonged episodes of inadequate support may not be well tolerated and may lead to life-threatening injuries,” according to the advisory.
What healthcare providers need to know
Johnson & Johnson MedTech has emphasized that customers should all review the new instructions and have another AIC available on hand in case a device failure does occur. The company also shared specific images that show what the AIC screen will look like if the AIC is not properly connecting with an Impella device.
In addition, Johnson & Johnson MedTech has pointed to the importance of reviewing these details and sharing them with colleagues and customers as necessary.
“If any affected products have been forwarded to another facility, contact that facility and provide them with this notice,” according to the advisory.
Johnson & Johnson MedTech’s Automated Impella Controller. Image courtesy of Johnson & Johnson MedTech.
Notes from the manufacturer
Johnson & Johnson shared the following statement with Cardiovascular Business:
On June 26, 2025, Johnson & Johnson MedTech issued a device correction for the AIC after identifying a potential issue where the AIC may not detect an Impella pump when connected. This can occur with any version of the pump and affects AICs globally.
A review of complaints from January 2021 to May 2025 showed a 0.02% occurrence rate. In the interest of patient safety, we informed U.S. customers with guidance to help mitigate risk in the event AIC detection issues occur. Global notifications will follow local requirements. As outlined in the Instructions for Use, hospitals should have a backup AIC console available.
Importantly, this is not a product removal. The AIC and Impella pumps remain on the market and available for patient care. 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.
The recent history of Johnson & Johnson MedTech’s Automated Impella Controllers
These devices display patient data when Johnson & Johnson MedTech’s line of Impella heart pumps are being used to provide mechanical circulatory support. They have been involved in a series of FDA early alerts and recalls in recent months. Click here, here and here for additional details.
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.
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.