FDA announces Class I recall due to heart pump controller issue
The U.S. Food and Drug Administration (FDA) has officially classified an ongoing safety issue with Johnson & Johnson MedTech’s Automated Impella Controller (AIC) as a Class I recall. The agency previously shared an early alert about the issue, but it was still reviewing the situation at the time.
Class I recalls are the most serious category, highlighting the FDA’s concerns that these devices could “cause serious adverse health consequences or death.”
Device issue linked to three patient deaths
The AIC displays patient data when Johnson & Johnson MedTech’s line of Impella heart pumps are in use. The safety concern at the heart of this recall involves the device not detecting 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.” The FDA first notified healthcare providers about this risk in late June.
This connection error can occur with all versions of the Impella technology. It has been linked to a total of three patient deaths.
Johnson & Johnson MedTech’s Automated Impella Controller. Image courtesy of Johnson & Johnson MedTech.
Recommended actions
The Class I recall covers a total of more than 11,000 units distributed all over the world. No products need to be quarantined or removed from the market at this time.
Johnson & Johnson MedTech noted that this connection issue has been observed in approximately 0.02% of devices. The company also highlighted the importance of keeping a backup AIC on hand.
“Importantly, this is not a product removal,” a Johnson & Johnson MedTech spokesperson told Cardiovascular Business. “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 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.