Abiomed recalls percutaneous heart pump for cardiogenic shock
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Key takeaways:
- Abiomed is recalling specific Impella 5.5 left ventricular device systems due to product leakage.
- The FDA designated the recall as class I, the most serious.
Abiomed is recalling specific left ventricular assist device sets used for people with cardiomyopathy due to customer complaints about purge fluid leaking from the sidearm of the pump, according to an FDA press release.
Abiomed is recalling specific Impella 5.5 with SmartAssist systems distributed between Sept. 28, 2021, and March 6, 2023. The system is used for up to 14 days when there is ongoing cardiogenic shock less than 48 hours after an acute MI, open-heart surgery or due to cardiomyopathy. The FDA identified this as a class I recall, the most serious type of recall, meaning use of these devices may cause serious injuries or death.
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The latest versions of the Impella 5.5 with SmartAssist sets with a preinstalled sidearm retainer and a new yellow luer are not part of the recall, Johnson & Johnson, the parent company of Abiomed, stated in an email to Healio.
The recalled product code is 0550-0008; product serial numbers are available in the recall database entry.
If a purge leak occurs, the system will experience low purge pressures, prompting alarms and requiring evaluation, according to the release. 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 stated in the release.
Abiomed reported 179 complaints, three injuries and no deaths related to the recall, according to the FDA. The company sent an urgent medical device recall letter to customers April 17.
Customers with questions about the recall should contact Abiomed’s clinical support center at 800-422-8666.
Reference:
- FDA recall database. Available at: Class 1 Device Recall Impella 5.5 with SmartAssist (fda.gov). Accessed June 6, 2023.
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