---
schema_version: "secwatch.filing_event.v1"
accession: "0001145197-26-000095"
form_type: "8-K"
ticker: "PODD"
cik: "0001145197"
company_name: "INSULET CORP"
filed_at: "2026-04-29T23:59:59+00:00"
generated_at: "2026-05-15T01:35:56.509707+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Insulet Corporation updates on voluntary Medical Device Correction with FDA reporting 476 serious injuries

## Summary
- On March 12, 2026, Insulet issued a press release regarding a voluntary Medical Device Correction with 18 Serious Adverse Events reported.
- On April 10, 2026, Insulet added 13 expired lots to the correction, stating no impact on previously estimated financial impact.
- As of April 17, 2026, FDA reported 476 serious injuries and no deaths associated with the device issue; Insulet clarified these are Medical Device Reports, not confirmed adverse events.
- The updated communication on April 10 noted 29 confirmed Serious Adverse Events, up from the initial 18.

## SEC filing metadata
- accession: 0001145197-26-000095
- form_type: 8-K
- ticker: PODD
- cik: 0001145197
- company_name: INSULET CORP
- filed_at: 2026-04-29T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1145197/000114519726000095/0001145197-26-000095-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1145197/000114519726000095/podd-20260429.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001145197-26-000095
- JSON: https://secwatch.observer/filing/0001145197-26-000095.json
- Plain text: https://secwatch.observer/filing/0001145197-26-000095.txt

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