Abiomed Recalls Specific Impella 5.5 with SmartAssist for 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. Use of these devices may cause serious injuries or death.

The Impella 5.5 with SmartAssist System is used for up to 14 days to support the pumping chambers of the heart (ventricles) when there is ongoing cardiogenic shock that occurs less than 48 hours after a severe heart attack (acute myocardial infarction), open-heart surgery, or when the heart is not functioning well due to a condition called cardiomyopathy.

Abiomed is recalling specific Impella 5.5 with SmartAssist sets 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. 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 reports 179 complaints, three injuries and no deaths related to this recall.

On April 17, 2023, Abiomed sent an Urgent Medical Device Recall letter to customers. The letter included the following recommended actions for customers and users:

Customers with questions about this recall should contact Abiomed's Clinical Support Center at 1-800-422-8666.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.

06/05/2023