# FDA recall Z-0290-2024

> **Maquet Medical Systems USA** · Class II · device recall initiated 2023-10-12.

## Product

Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)

## Reason for recall

It was found that the fixation (weld) employed by the supplier of the nut bolt to the slide rail plate was insufficient. The deficient weld allows the nut bolt to break off from the slide rail plate with slight manual force.

## Distribution

US Nationwide.

## Key facts

- **Recall number:** Z-0290-2024
- **Recalling firm:** Maquet Medical Systems USA
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-12
- **Report date:** 2023-11-15

- **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-0290-2024

## Citation

> AI Analytics. FDA recall Z-0290-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0290-2024. Source: US FDA. Licensed CC0.

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