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

InspireMD, Inc.

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.

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