# FDA recall Z-1831-2024

> **Maquet Medical Systems USA** · Class II · device recall initiated 2024-04-15.

## Product

CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.

## Reason for recall

The firm identified that the measured patient leakage current in some devices significantly exceeded expected levels.

## Distribution

US Nationwide distribution in the states of NJ & TX.

## Key facts

- **Recall number:** Z-1831-2024
- **Recalling firm:** Maquet Medical Systems USA
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-15
- **Report date:** 2024-05-22

- **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-1831-2024

## Citation

> AI Analytics. FDA recall Z-1831-2024. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-1831-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*