Newsroom category: FAQ

Why did the FDA Issue Its Highest Alert for Certain Heart Pumps?

July 5, 2024

On March 21, 2024, the US Food and Drug Administration (FDA) classified the recall of Abiomed’s Impella left-sided pumps as a “Class I recall,”  the agency’s “most serious type of recall.” This is a classification the FDA uses when a device imposes a risk of serious injuries or death. The FDA warned that using these […]

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