The U.S. Food and Drug Administration (FDA) has announced that Abiomed is recalling more than 450 of its Impella heart pumps due to a heightened risk of purge fluid leaking from the purge sidearm of the pump.
The recall includes 466 units of the Impella 5.5 with SmartAssist. All devices were distributed from September 2021 to March 2023, and the recall was first initiated on April 17, 2023. The FDA has labeled this as a Class I recall, which means using these devices can lead to significant injuries, including death.
“If a purge leak occurs the system will experience low purge pressures, prompting alarms and requiring evaluation,” according to the FDA’s advisory. “If the leak issue is not resolved, persistent low purge pressure and purge flow may lead to pump stop and loss of therapy. In patients who are critical, failure of the pump’s support can lead to further deterioration and worsening of their already critical condition and may even lead to serious injury or death.”
There have been 179 complaints so far about this issue, including reports of three injuries.
Abiomed is urging all customers to see if they have any of the devices included in this recall. If they do, they should not use these products “unless no other product is available.” Customers should reach out to Abiomed to coordinate any product returns as necessary.
If customers do need to implant one of these devices because no other options are available, Abiomed has provided several steps that should be followed. These steps include ensuring the device’s sidearm retainer is in place and seeing that no sterilization solutions made with isopropyl alcohol are applied to the sidearm or purge filter. The full list is part of the FDA’s advisory and was sent directly to customers.
As always, both healthcare providers and patients can report adverse events to the FDA using the agency’s MedWatch Online Voluntary Reporting Form.
Additional details from Abiomed are available as a PDF here.
Note: The latest versions of the Impella 5.5 with SmartAssist, with the preinstalled sidearm retainer and the new yellow luer, are not a part of this recall.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.