Abiomed has recalled 466 of its Impella 5.5 with SmartAssist heart pumps after receiving customer complaints about purge fluid leaking from the purge sidearm of the pump.
“If a purge leak occurs, the system will experience low purge pressures, prompting alarms and requiring evaluation,” the US Food and Drug Administration (FDA) says in an advisory posted on its website.
“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,” the FDA says.
The FDA has identified this as a class I recall, the most serious type because of the potential for serious injury or death.
To date, Abiomed says it has received 179 complaints; there have been three injuries and no deaths related to this problem.
The Impella 5.5 with SmartAssist System is used for up to 14 days to support the ventricles in the setting of ongoing cardiogenic shock that occurs less than 48 hours after acute myocardial infarction, open-heart surgery, or when the heart is not functioning well owing to cardiomyopathy.
All the devices that are being recalled were distributed from September 2021 to March 2023. Detailed product information is available on the FDA website.
Abiomed has sent an urgent medical device recall letter to customers asking them to review their inventory to check for any recalled product and to contact Abiomed customer support to coordinate return of the product.
Customers are advised not to use affected products unless no other product is available. The letter includes “best practices” for situations in which no other option is available and the device must be used until a replacement is available.
Customers with questions about this recall should contact Abiomed’s clinical support center at 1-800-422-8666.
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