Abiomed Recalls Specific Sets of Impella 5.5 With SmartAssist for Purge Fluid Leaks

June 5, 2023—The FDA advised that Abiomed recalled specific Impella 5.5 with SmartAssist heart pump devices (Product Code: 0550-0008) because of purge fluid leaks that can cause pump stop and loss of support. The FDA has identified this as a Class I recall, the most serious type of recall, indicating that use of these devices may cause serious injuries or death. Abiomed reported that there were 179 complaints, three injuries, and no deaths related to this recall.

Abiomed’s Impella 5.5 with SmartAssist system is used for up to 14 days to support ventricles when there is ongoing cardiogenic shock that occurs < 48 hours after an acute myocardial infarction, open heart surgery, or when the heart is not functioning well because of cardiomyopathy.

The FDA reported that on April 17, 2023, Abiomed initiated the recall of specific Impella 5.5 with SmartAssist sets after receiving customer complaints about purge fluid leaking from the purge sidearm of the pump. Abiomed sent an Urgent Medical Device Recall letter to customers that included recommended actions for customers and users. The letter is available for downloading from the company’s website here.

According to the FDA notification, the recall involved devices that were distributed between September 28, 2021, to March 6, 2023. FDA reported that 466 devices were recalled in the United States. The product serial numbers are available on the FDA’s recall database here.

The database addressed to physicians advised, “The benefits of using the pump outweigh the risks of pump stop due to purge leaks. To mitigate leaks from sidearm damage and/or the yellow luer, it is critical to refer to the Important Information section below for best practices in the event you must use an affected Impella 5.5 with SmartAssist set while you wait for a replacement pump.” The database also noted that Abiomed would replace all affected pumps that are still in physician inventories using a phased replacement approach.

As explained by the FDA, if a purge leak occurs, the system will experience low purge pressures, prompting alarms and requiring evaluation. 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.

Abiomed noted that the latest versions of the Impella 5.5 with SmartAssist sets with the preinstalled sidearm retainer and the new yellow luer are not part of this recall.

In a statement provided to Cardiac Interventions Today, the company advised, “At Abiomed, our first priority is our patients, including the safe and effective use of our products. Abiomed has notified customers and the FDA about this voluntary recall and provided detailed instructions to customers on how to return or replace the subjected lots.”