# FDA recall Z-0589-2024

> **Maquet Cardiovascular, LLC** · Class II · device recall initiated 2023-10-31.

## Product

Acrobat-i Vacuum Positioner System, Model Number XP-5000Z

## Reason for recall

The Positioner Arm may not tighten or lock during normal use.

## Distribution

US Nationwide.  Global Distribution.

## Key facts

- **Recall number:** Z-0589-2024
- **Recalling firm:** Maquet Cardiovascular, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-31
- **Report date:** 2023-12-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0589-2024

## Citation

> AI Analytics. FDA recall Z-0589-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0589-2024. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*