FDA shares warning after Johnson & Johnson heart pump controllers linked to 3 deaths
The U.S. Food and Drug Administration (FDA) is alerting the public about a new safety issue associated with Johnson & Johnson MedTech’s Automated Impella Controller (AIC). The device displays patient data when the company’s line of Impella heart pumps are being used to provide mechanical circulatory support.
Johnson & Johnson MedTech has received reports of the AIC not detecting the 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,” the agency warned in a new advisory.
The issue can occur with all versions of the Impella technology. As of June 13, three patient deaths have been linked to this connection issue.
Johnson & Johnson MedTech sent a letter to all affected customers, highlighting the importance of keeping a backup AIC on hand. The company also provided specific details about what to look for during console-to-console transfers and the start of each case.
No products need to be quarantined or removed from the market at this time. Instead, this alert is designed to increase awareness about the connection issue going forward.
The FDA is still reviewing the available information. Whether or not this will be ruled a Class I recall is not yet known.
Johnson & Johnson shares a statement about connection issues
Johnson & Johnson shared the following statement with Cardiovascular Business:
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 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 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.