Abiomed Recalls Certain Impella 5.5 Devices Due to Risk of Purge-Fluid Leaks

Abiomed is recalling some of its Impella 5.5 with SmartAssist devices in response to complaints about purge fluid leaking from the purge sidearm of the pump. Today, the US Food and Drug Administration sent out an alert identifying it as a Class I recall, the most serious type.

“If a purge leak occurs, the system will experience low purge pressures, prompting alarms and requiring evaluation,” the agency says in its recall alert. “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.”

Impella 5.5 with SmartAssist is intended to provide mechanical circulatory support for up to 14 days in patients with cardiogenic shock occurring within 48 hours of acute MI or open heart surgery, or in the setting of cardiomyopathy.

Initiated by the company in April, the recall applies to 466 Impella 5.5 devices with product code 0550-0008 that were distributed between September 28, 2021, and March 6, 2023. There have been a total of 179 complaints, three injuries, and no deaths related to the issue.

An Urgent Medical Device Recall letter outlines further details on how to return affected products and offers best practices on how to use these devices, if necessary, while awaiting replacements. It also specifies: "The Impella 5.5 with SmartAssist Sets with the preinstalled Sidearm Retainer and the new yellow luer are not part of this recall (removal)."