June 5, 2023

FDA: Class I recall of specific Abiomed Impella 5.5 with SmartAssist heart pumps

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA), on June 5, identified the recall by Abiomed of specific Impella 5.5 with SmartAssist heart pumps as Class I, the most serious.

The recall was initiated because of fluid leaking from the purge sidearm of the pump. If the leak issue is not resolved, persistent low purge pressure and purge flow may cause the pump to stop and the loss of support to the pumping chambers of the heart.

The company reports 179 complaints, 3 injuries, and no deaths related to this issue.

The product code is 0550-0008. Distribution dates were September 28, 2021 to March 6, 2023.

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