# FDA recall Z-1310-2024

> **Mc3 Inc** · Class II · device recall initiated 2023-10-11.

## Product

NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature.  Product Number:  48135, 48135E

## Reason for recall

May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1310-2024
- **Recalling firm:** Mc3 Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-11
- **Report date:** 2024-03-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dexter, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1310-2024

## Citation

> AI Analytics. FDA recall Z-1310-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1310-2024. Source: US FDA. Licensed CC0.

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