---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-24-049660"
form_type: "8-K"
ticker: "NUWE"
cik: "0001506492"
company_name: "Nuwellis, Inc."
filed_at: "2024-12-16T23:59:59+00:00"
generated_at: "2026-05-29T02:53:11.047244+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Nuwellis voluntarily recalls AquaFlexFlow UF 500 Plus blood circuits over mismatch alarms

## Summary
- Recall of specific lots due to 'Ultrafiltrate Weight Mismatch' alarms; may cause excess fluid removal leading to acute volume depletion.
- Five reported incidences of product failures; three caused patient dehydration requiring fluid administration.
- Recall conducted with FDA knowledge; FDA has not yet classified recall class.
- Affected product: AquaFlexFlow UF 500 Plus blood circuit used with Aquadex Smartflow or FlexFlow systems.

## SEC filing metadata
- accession: 0001140361-24-049660
- form_type: 8-K
- ticker: NUWE
- cik: 0001506492
- company_name: Nuwellis, Inc.
- filed_at: 2024-12-16T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1506492/000114036124049660/0001140361-24-049660-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1506492/000114036124049660/ef20040192_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-24-049660
- JSON: https://secwatch.observer/filing/0001140361-24-049660.json
- Plain text: https://secwatch.observer/filing/0001140361-24-049660.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.