# FDA recall Z-0831-2025

> **Nuwellis Inc** · Class I · device recall initiated 2024-12-11.

## Product

nuwellis AquaFlexFlow UF 500 Plus, REF 114156, Catalog Number A06163, extracorporeal blood circuit which is used with the Aquadex SmartFlow or Aquadex FlexFlow System

## Reason for recall

The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or  Excessive Weight Mismatch  Alarms while in use. If not addressed, this failure could result in excess fluid removal from a patient leading to Acute Volume Depletion. This failure is especially serious when the Aquadex System is being used on pediatric patients.

## Distribution

US Nationwide Distribution and the country of Hong Kong

## Key facts

- **Recall number:** Z-0831-2025
- **Recalling firm:** Nuwellis Inc
- **Classification:** Class I
- **Product type:** device
- **Status:** Completed
- **Initiation date:** 2024-12-11
- **Report date:** 2025-01-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Eden Prairie, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0831-2025

## Citation

> AI Analytics. FDA recall Z-0831-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0831-2025. Source: US FDA. Licensed CC0.

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