FDA investigating Johnson & Johnson medical devices again after 5 injuries
The U.S. Food and Drug Administration (FDA) is tracking another safety concern with Johnson & Johnson MedTech’s Automated Impella Controllers (AICs). It is the third investigation of these devices in the last three months.
This latest issue is related to “purge retainer failures,” including cracks, customers have experienced during purge disc insertion or removal.
“Failures impacting purge pressure and detection of the purge disc may lead to errors, alarms, and potential interruptions in hemodynamic support when the AIC may need to be replaced,” according to the FDA’s advisory. “Purge retainer failures may result in a pump stop with resultant loss of hemodynamic support. Loss of hemodynamic support poses a serious risk to patient health and may lead to permanent impairment or death.”
As of Aug. 27, these failures have been linked to five serious patient injuries.
What should customers do?
Johnson & Johnson MedTech will be servicing these devices to perform purge retainer updates and then returning them to customers. The updates are specifically designed to eliminate these failures going forward.
While waiting for that update to occur, customers can still use the devices like normal.
Johnson & Johnson MedTech’s Automated Impella Controller. Image courtesy of Johnson & Johnson MedTech.
Another safety concern for Johnson & Johnson MedTech heart pump controllers
The FDA has reviewed multiple safety risks with Johnson & Johnson MedTech’s AICs in the few months. There was a connection issue that resulted in a Class I recall, as well as manufacturing error that prompted a separate Class I recall. It is unclear at this time if this latest issue will lead to a third Class I recall—the FDA sent out this early alert while it was still evaluating the available information.
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.