# FDA recall Z-0440-2024

> **Abiomed, Inc.** · Class II · device recall initiated 2023-10-10.

## Product

Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.

## Reason for recall

Pump not detected as connected to controller due to software issue.

## Distribution

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

## Key facts

- **Recall number:** Z-0440-2024
- **Recalling firm:** Abiomed, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2023-10-10
- **Report date:** 2023-12-13
- **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-0440-2024

## Citation

> AI Analytics. FDA recall Z-0440-2024. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0440-2024. Source: US FDA. Licensed CC0.

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