{"schema_version":"secwatch.filing_event.v1","accession":"0001639691-22-000112","form_type":"8-K","ticker":"LIVN","cik":"0001639691","company_name":"LivaNova PLC","filed_at":"2022-12-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:51.530219+00:00","generated_at":"2026-06-21T05:27:09.384044+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"LivaNova announces FDA Warning Letter closed for Munich and Arvada facilities","bullets":["FDA issued Warning Letter in Dec 2015 over regulatory violations at two facilities.","Company completed remediation actions to address alleged violations and observations.","Received FDA communication dated Nov 28, 2022 indicating the Warning Letter is closed.","No penalty or ongoing compliance obligations detailed in the filing."],"urls":{"canonical":"https://secwatch.observer/filing/0001639691-22-000112","json":"https://secwatch.observer/filing/0001639691-22-000112.json","markdown":"https://secwatch.observer/filing/0001639691-22-000112.md","text":"https://secwatch.observer/filing/0001639691-22-000112.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1639691/000163969122000112/0001639691-22-000112-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1639691/000163969122000112/livn-20221212.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-21T05:27:09.384044+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"}