{"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","discovered_at":"2026-05-14T18:02:34.620806+00:00","generated_at":"2026-05-15T12:56:34.330069+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Insulet voluntarily corrects Omnipod 5 pods; 18 serious adverse events, up to $40M cost","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001145197-26-000081","json":"https://secwatch.observer/filing/0001145197-26-000081.json","markdown":"https://secwatch.observer/filing/0001145197-26-000081.md","text":"https://secwatch.observer/filing/0001145197-26-000081.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T12:56:34.330069+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}