# FDA recall Z-0983-2019

> **Maquet Cardiovascular, LLC** · Class II · device recall initiated 2019-01-24.

## Product

AXIUS Blower Mister  Product Code/REF Number: CB-1000    The Axius Blower Mister is intended to clear an anastomotic site for improved visibility

## Reason for recall

Potential lack of carbon dioxide (CO2) flow that may result in a procedural delay during off-pump coronary artery bypass (OPCAB).

## Distribution

Worldwide distribution: US (Nationwide) and countries of: Australia, Belgium, Canada, Czech Republic, France, Germany, Korea, Netherlands, Russia, Spain, Switzerland, and United Kingdom.

## Key facts

- **Recall number:** Z-0983-2019
- **Recalling firm:** Maquet Cardiovascular, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-24
- **Report date:** 2019-03-13
- **Termination date:** 2020-07-13

- **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-0983-2019

## Citation

> AI Analytics. FDA recall Z-0983-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0983-2019. Source: US FDA. Licensed CC0.

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