A voluntary medical device correction has escalated with the FDA reporting 476 serious injuries, far exceeding the company's 29 confirmed events. This creates significant operational, reputational, and legal risk, requiring immediate focus on quality management, customer communication, and regulatory compliance.
Filing excerpt
On April 29, 2026, the U.S. Food and Drug Administration (FDA) included language on their website that said “As of April 17, Insulet has reported 476 serious injuries and no deaths associated with this issue”.
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This page shows a preview. The full sec-8k record in the Signal API and MCP can also have these 8 fields. Some fields are empty for some signals.
Company
linkedin_urlValue in the APIindustriesValue in the APIemployee_count_lowValue in the APIemployee_count_highValue in the APIrevenueValue in the APIdescriptionValue in the APISignal
signal_nameValue in the APIassociationValue in the APIGET /v1/signals/08958d2d-5bb0-4fff-ab79-6ee5ed58b699 returns this record as JSON. POST /v1/companies/enrich returns every signal for insulet.com.
{
"signal_id": "08958d2d-5bb0-4fff-ab79-6ee5ed58b699",
"signal_type": "sec-8k",
"signal_subtype": "productLiability",
"detected_at": "2026-05-05T08:48:16.144+00:00",
"company": {
"name": "Insulet",
"domain": "insulet.com"
},
"data": {
"detail": "A voluntary medical device correction has escalated with the FDA reporting 476 serious injuries, far exceeding the company's 29 confirmed events. This creates significant operational, reputational, and legal risk, requiring immediate focus on quality management, customer communication, and regulatory compliance.",
"metrics": {
"timeframe": "immediate"
},
"summary": "Insulet faces product liability risk with 476 serious injuries reported to FDA for device correction.",
"excerpts": "On April 29, 2026, the U.S. Food and Drug Administration (FDA) included language on their website that said “As of April 17, Insulet has reported 476 serious injuries and no deaths associated with this issue”.",
"relevance": 0.9,
"sentiment": "negative",
"confidence": "high",
"source_url": "https://www.sec.gov/Archives/edgar/data/1145197/000114519726000095/podd-20260429.htm",
"filing_date": "2026-04-29",
"filing_year": 2026,
"fiscal_year_end": "04/29",
"sales_relevance": "Quality management needed",
"signal_category": "risk"
}
}
curl https://signals.autobound.ai/v1/signals/08958d2d-5bb0-4fff-ab79-6ee5ed58b699 \
-H "X-API-KEY: $AUTOBOUND_API_KEY"curl -X POST https://signals.autobound.ai/v1/companies/enrich \
-H "X-API-KEY: $AUTOBOUND_API_KEY" \
-H "Content-Type: application/json" \
-d '{"domain":"insulet.com","limit":20}'Long text fields are shortened on this page.
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