---
title: "Automated Impella Controller (AIC), product number 0042-040-US with software ... — FDA record Z-0441-2024 | Is It on Recall"
description: "Pump not detected as connected to controller due to software issue."
url: https://isitonrecall.com/recall/fda-device-z-0441-2024-automated-impella-controller-aic-product-number-0042-040-us-with-software-versions-v8-4-and-v8-4-1/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1. — FDA record Z-0441-2024

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Oct 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
- **Reason**: Pump not detected as connected to controller due to software issue.
- **Classification**: Class II
- **Recalling firm**: Abiomed, Inc.
- **Quantity**: Not supplied
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0441-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0441-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI (GTIN): 00813502011401, serial numbers IC8386, IC8391 and IC8617. |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US: AZ, CA, FL, NY & VA.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Arizona](https://isitonrecall.com/state/arizona/)
- [California](https://isitonrecall.com/state/california/)
- [Florida](https://isitonrecall.com/state/florida/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Virginia](https://isitonrecall.com/state/virginia/)

## Dates in the source

- **Report date**: Dec 13, 2023
- **Recall initiation date**: Oct 10, 2023
- **Center classification date**: Dec 1, 2023
- **Termination date**: Mar 6, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0441-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Abiomed, Inc. records](https://isitonrecall.com/brand/abiomed-inc/)