# FDA recall Z-1175-2024

> **Abiomed, Inc.** · Class II · device recall initiated 2021-03-01.

## Product

Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US.  Used with Impella Ventricular Support Systems (cardiovascular)

## Reason for recall

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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1175-2024
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-01
- **Report date:** 2024-02-28
- **Termination date:** 2025-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Danvers, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1175-2024

## Citation

> AI Analytics. FDA recall Z-1175-2024. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-1175-2024. Source: US FDA. Licensed CC0.

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