secwatch.observer — SEC 8-K summary
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Issuer:     InspireMD, Inc. (NSPR)
CIK:        0001433607
Form:       8-K
Filed at:   2026-05-01T23:59:59+00:00
Accession:  0001493152-26-020891
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1433607/000149315226020891/0001493152-26-020891-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1433607/000149315226020891/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-020891

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer