{"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","discovered_at":"2026-05-14T18:03:08.626463+00:00","generated_at":"2026-05-29T02:53:11.047244+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"Nuwellis voluntarily recalls AquaFlexFlow UF 500 Plus blood circuits over mismatch alarms","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-24-049660","json":"https://secwatch.observer/filing/0001140361-24-049660.json","markdown":"https://secwatch.observer/filing/0001140361-24-049660.md","text":"https://secwatch.observer/filing/0001140361-24-049660.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T02:53:11.047244+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}