Safety notice

Early Alert: Heart Pump Controller Issue from Abiomed

Headline as published by U.S. Food and Drug Administration (MedWatch).

Read at U.S. Food and Drug Administration (MedWatch)

Abiomed is removing certain Impella Controllers with various hardware, firmware, and/or software updates based on a retrospective review of servicing records.

From U.S. Food and Drug Administration (MedWatch)’s feed

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