Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes.: Impella Controller, Packaged, CA - Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, elec

Source: FDA | Recall date: 06/03/2026

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Affected product: Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes.: Impella Controller, Packaged, CA

Summary: Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles.

Hazard: Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles.

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