FreshRecalls

Automated Impella Controller (AIC): recall status

⚠ Recall found. Automated Impella Controller (AIC) is named in 2 official recalls in our current data. Details and the official notices are below — act on the remedy in the official notice.

Brand
Abiomed

Recalls naming this model

FDA Class I · Medical device · June 24, 2026

Automated Impella Controller (AIC) recall — Abiomed, Inc.

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

Official ID Z-2360-2026 · Official record ↗

FDA Class I · Medical device · June 3, 2026

Automated Impella Controller (AIC) recall — Abiomed, Inc.

A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented th…

Official ID Z-2211-2026 · Official record ↗

See all Abiomed recalls →

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Compiled from official public-domain CPSC, NHTSA, and FDA data. Sources last checked July 24, 2026 at 3:00 AM UTC.