# FDA recall Z-0986-2019

> **Maquet Cardiovascular Us Sales, Llc** · Class I · device recall initiated 2019-02-08.

## Product

Cardiohelp Emergency Drive, Part No. 70104.8002    Product Usage:  The Cardiohelp Emergency Drive is used in emergencies to manually drive the disposable if the Cardiohelp-i fails.

## Reason for recall

Upon servicing the gearwheel in the Emergency Drive the gearwheel may have been re-assembled  incorrectly, leading to the inadequate operation of the Emergency Drive.

## Distribution

US Nationwide Distribution in the states of California, Florida, Illinois, Kentucky, Michigan, and New York.

## Key facts

- **Recall number:** Z-0986-2019
- **Recalling firm:** Maquet Cardiovascular Us Sales, Llc
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-08
- **Report date:** 2019-04-03
- **Termination date:** 2020-05-14

- **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-0986-2019

## Citation

> AI Analytics. FDA recall Z-0986-2019. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0986-2019. Source: US FDA. Licensed CC0.

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