Abiomed recalls AIC controllers with software version 8.4 for potential pump recognition failure. Affected units require software update to prevent device malfunction.
Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC.
Abiomed is recalling AIC controllers with software version 8.4 that may not recognize the Impella pump. This could cause the device to malfunction during use. Affected users should update to version 8.5 software.
The software version 8.4 has a bug that prevents the AIC from recognizing the Impella pump. This could lead to the device malfunctioning during use. The issue was resolved in version 8.5.
Healthcare professionals using Abiomed AIC controllers with Impella Ventricular Support Systems. Patients using these devices are at low risk if the software is updated.
Check for product codes 0042-0000-US, 0042-0010-US, or 0042-0040-US. The software version should be 8.4 or 8.4.1. The device is used with Impella Ventricular Support Systems.
Download and install the updated software version 8.5 from Abiomed's website or through the device's interface.
The recall addresses a software issue that could cause pump recognition failure, but it is not a safety hazard in normal use. The risk is low and resolved by updating to version 8.5.
Check your product code: 0042-0000-US, 0042-0010-US, or 0042-0040-US. The software version should be 8.4 or 8.4.1.
No, you can continue using the device after updating to software version 8.5. The recall does not require immediate discontinuation.
We’ve drafted a message you can send Abiomed to request your refund or repair — edit it as you like.
Subject: Recall Z-1175-2024 — Abiomed Abiomed Hello, I own a Abiomed that is covered by recall Z-1175-2024 from Abiomed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
