# FDA recall Z-0137-2024

> **Maquet Cardiovascular, LLC** · Class II · device recall initiated 2023-09-13.

## Product

Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.  Product Code: OM-10000Z

## Reason for recall

Housing Mount Jaw of these devices breaking during normal use and may result in injury to the epicardial tissue or vasculature, or a coronary artery or previously placed bypass graft, or could result in procedural delay and/or conversion.

## Distribution

Nationwide  Foreign: AT BE DE ES FR GB IT JP KR LU NL PL PT TR

## Key facts

- **Recall number:** Z-0137-2024
- **Recalling firm:** Maquet Cardiovascular, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-13
- **Report date:** 2023-11-01

- **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-0137-2024

## Citation

> AI Analytics. FDA recall Z-0137-2024. Retrieved 2026-07-09 from https://api.ai-analytics.org/recall/Z-0137-2024. Source: US FDA. Licensed CC0.

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