---
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"
generated_at: "2026-06-21T05:27:09.384044+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# LivaNova announces FDA Warning Letter closed for Munich and Arvada facilities

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001639691-22-000112
- JSON: https://secwatch.observer/filing/0001639691-22-000112.json
- Plain text: https://secwatch.observer/filing/0001639691-22-000112.txt

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