FDA confirms Class I recall for Johnson & Johnson devices due to durability concerns
The U.S. Food and Drug Administration (FDA) has confirmed that a safety concern it was investigating with Johnson & Johnson MedTech’s Automated Impella Controllers (AICs) has resulted in a Class I recall. The agency reserves Class I recalls for issues that could potentially lead to a serious injury or death.
This latest issue with the Johnson & Johnson MedTech AICs revolves around “purge retainer failures,” including cracks, that customers have experienced during purge disc insertion or removal.
The FDA first announced it was investigating this issue in September, sharing an early alert that highlighted the potential risks of these failures.
“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,” the agency said at the time. “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, this ongoing issue had been linked to five serious injuries and no deaths.
Read more about the Class I recall here. Additional details from Johnson & Johnson MedTech are available here.
What should customers do?
Johnson & Johnson MedTech has said that hospital inventory can continue to be used. Inventory not actively being used should be returned for the necessary updates to be made. Company representatives will reach out to customers to schedule these returns.
Johnson & Johnson MedTech also emphasized that just 0.61% of AICs have been linked to specific user complaints.
Heart pump controllers linked to multiple safety issues in recent months
The FDA has reviewed multiple safety concerns associated with Johnson & Johnson MedTech’s AICs in the last months. There was a connection issue that resulted in a Class I recall, a manufacturing error that prompted a separate Class I recall, these purge retainer failures and then a cybersecurity risk that was just announced on Oct. 10.
Abiomed was acquired by Johnson & Johnson 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.
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.