---
schema_version: "secwatch.filing_event.v1"
accession: "0001388658-23-000070"
form_type: "8-K"
ticker: "IRTC"
cik: "0001388658"
company_name: "iRhythm Holdings, Inc."
filed_at: "2023-05-30T23:59:59+00:00"
generated_at: "2026-06-14T11:26:36.476614+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# FDA warning letter to iRhythm for Zio AT System quality and reporting violations

## Summary
- FDA alleges non-conformities in medical device reporting and quality system requirements for Zio AT System.
- Warning letter follows August 2022 inspection of iRhythm's Cypress, CA facility; company intends to respond within specified timeframe.
- Company has taken corrective measures on prior FDA Form 483 observations and will continue remediation efforts.
- Warning letter does not restrict manufacturing, production, or shipment of products in U.S. or require product withdrawal at this time.
- iRhythm believes no material financial impact absent further adverse FDA action, but additional regulatory actions remain possible.

## SEC filing metadata
- accession: 0001388658-23-000070
- form_type: 8-K
- ticker: IRTC
- cik: 0001388658
- company_name: iRhythm Holdings, Inc.
- filed_at: 2023-05-30T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1388658/000138865823000070/0001388658-23-000070-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1388658/000138865823000070/irtc-20230525.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001388658-23-000070
- JSON: https://secwatch.observer/filing/0001388658-23-000070.json
- Plain text: https://secwatch.observer/filing/0001388658-23-000070.txt

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