# FDA recall Z-0887-2022

> **Maquet Cardiovascular, LLC** · Class II · device recall initiated 2022-02-09.

## Product

Ultima Activator II Reusable Drive Mechanism, part # C-UA-5001.  Labeled REF UA-5001.

## Reason for recall

Potential for corrosion on the pins of the Ultima Activator II Reusable Drive Mechanism. Harms may include allergic reaction, metal toxicity, and other delayed responses.

## Distribution

Worldwide - United States (AL, AZ, CA, FL, IL, KY, LA, MO, MT, NM, OH, PA, TX, WI), Germany, Republic of Korea (South Korea), Russia, Thailand, United Arab Emirates.

## Key facts

- **Recall number:** Z-0887-2022
- **Recalling firm:** Maquet Cardiovascular, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-02-09
- **Report date:** 2022-04-13

- **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-0887-2022

## Citation

> AI Analytics. FDA recall Z-0887-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0887-2022. Source: US FDA. Licensed CC0.

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