---
schema_version: "secwatch.filing_event.v1"
accession: "0001613103-21-000067"
form_type: "8-K"
ticker: "MDT"
cik: "0001613103"
company_name: "Medtronic plc"
filed_at: "2021-12-15T23:59:59+00:00"
generated_at: "2026-06-28T00:53:36.235212+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Medtronic Diabetes receives FDA warning letter; lowers Diabetes revenue guidance

## Summary
- FDA warning letter dated Dec 9 for Northridge, CA facility following July 2021 inspection related to MiniMed 600 series pump and controller recalls.
- No change to total company organic revenue growth or adjusted EPS guidance for Q3 or FY2022.
- Diabetes organic revenue now expected high-single-digit decline Q3 FY2022 (prev. mid-single-digit); mid-single-digit for FY2022 (prev. low-single-digit).
- Preliminary FY2023 total company revenue impact modeled at less than 0.5pp to ~1pp of growth; full guidance on Q4 FY2022 call.
- Company applying cross-company resources and external experts to address FDA observations.

## SEC filing metadata
- accession: 0001613103-21-000067
- form_type: 8-K
- ticker: MDT
- cik: 0001613103
- company_name: Medtronic plc
- filed_at: 2021-12-15T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1613103/000161310321000067/0001613103-21-000067-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1613103/000161310321000067/mdt-20211215.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001613103-21-000067
- JSON: https://secwatch.observer/filing/0001613103-21-000067.json
- Plain text: https://secwatch.observer/filing/0001613103-21-000067.txt

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