secwatch.observer — SEC 8-K summary
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Issuer:     Nuwellis, Inc. (NUWE)
CIK:        0001506492
Form:       8-K
Filed at:   2024-12-16T23:59:59+00:00
Accession:  0001140361-24-049660
Event type: regulatory
Sentiment:  negative
Materiality: 0.70
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1506492/000114036124049660/0001140361-24-049660-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1506492/000114036124049660/ef20040192_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-24-049660

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer