Automated Impella Controller (AIC) with the below product descriptions and corresponding P: recall status

⚠ Recalls found. Automated Impella Controller (AIC) with the below product descriptions and corresponding P is named in 3 official recalls in our current data:

• FDA Class II recall Z-3251-2026 — Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and stability of the pressure signal the AIC system performance depends on. 2. Software defects leading to unreliable or missing placement signal, unresponsive start Impella soft key during disconnect/reconnect, and false Position in Ventricle alarm in certain AICs.
• FDA Class I recall Z-3148-2026 — The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.
• FDA Class I recall Z-2238-2026 — 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. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.