---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-020891"
form_type: "8-K"
ticker: "NSPR"
cik: "0001433607"
company_name: "InspireMD, Inc."
filed_at: "2026-05-01T23:59:59+00:00"
generated_at: "2026-05-15T00:16:48.525990+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# InspireMD recalls CGuard Prime 135 cm delivery system due to performance issues; withdraws FY2026 revenue guidance

## Summary
- Voluntary recall of CGuard Prime 135 cm delivery system in US; technical success not met. No safety issues for implanted stent.
- FDA approval for original CGuard delivery system expected Q3 2026; delivery system used in over 70,000 cases worldwide.
- Withdrawing prior full year 2026 revenue guidance due to temporary halt in US commercialization pending FDA approval.
- FDA approved IDE for CGUARDIANS III pivotal study of SwitchGuard NPS for use with CGuard Prime 80 cm in TCAR procedures.
- Q1 2026 global unit sales up 53% YoY; US unit sales up 34% QoQ.

## SEC filing metadata
- accession: 0001493152-26-020891
- form_type: 8-K
- ticker: NSPR
- cik: 0001433607
- company_name: InspireMD, Inc.
- filed_at: 2026-05-01T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1433607/000149315226020891/0001493152-26-020891-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1433607/000149315226020891/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-020891
- JSON: https://secwatch.observer/filing/0001493152-26-020891.json
- Plain text: https://secwatch.observer/filing/0001493152-26-020891.txt

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