fda_recall · device_recall · critical

Abiomed, Inc. — Class I recall: Automated Impella Controller (AIC), for use with left heart support blood pump.…

Event date: 2026-06-24 00:00:00Z
Observed: 2026-07-09 22:52:06Z
Source ID: Z-2360-2026
Payload hash: 229d96f2ab33a5236bd5d501…

Summary

Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices. Status: Ongoing.

Entities

Abiomed, Inc.

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Informational only. Not legal, financial, or medical advice.