# FDA recall Z-0995-2023

> **Maquet Cardiovascular, LLC** · Class II · device recall initiated 2022-12-22.

## Product

Hemopro 2 with Vasoshield, Model VH-4001

## Reason for recall

Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event.

## Distribution

US Nationwide. Japan, Germany.

## Key facts

- **Recall number:** Z-0995-2023
- **Recalling firm:** Maquet Cardiovascular, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-22
- **Report date:** 2023-01-25

- **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-0995-2023

## Citation

> AI Analytics. FDA recall Z-0995-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0995-2023. Source: US FDA. Licensed CC0.

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