---
schema_version: "secwatch.filing_event.v1"
accession: "0001145197-26-000081"
form_type: "8-K"
ticker: "PODD"
cik: "0001145197"
company_name: "INSULET CORP"
filed_at: "2026-03-12T23:59:59+00:00"
generated_at: "2026-05-15T12:56:34.330069+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Insulet voluntarily corrects Omnipod 5 pods; 18 serious adverse events, up to $40M cost

## Summary
- Voluntary medical device correction for specific lots of Omnipod 5 Pods due to small tear in internal tubing causing under-delivery of insulin.
- Insulet received 18 reports of serious adverse events including hospitalization and DKA; no deaths reported.
- Affected pods represent approximately 1.5% of annual Omnipod 5 production; other products unaffected.
- Insulet expects up to $40 million in correction costs in 2026, excluded from adjusted results; 2026 guidance unchanged.
- Insulet implemented manufacturing process updates and notified FDA; customers can check lot numbers and get free replacements.

## SEC filing metadata
- accession: 0001145197-26-000081
- form_type: 8-K
- ticker: PODD
- cik: 0001145197
- company_name: INSULET CORP
- filed_at: 2026-03-12T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1145197/000114519726000081/0001145197-26-000081-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1145197/000114519726000081/podd-20260312.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001145197-26-000081
- JSON: https://secwatch.observer/filing/0001145197-26-000081.json
- Plain text: https://secwatch.observer/filing/0001145197-26-000081.txt

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