InspireMD recalls CGuard Prime 135cm delivery system, receives FDA approval for pivotal study

Filed May 1, 2026 · Period ending May 1, 2026 · ~1 min read

Key Changes

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  Company initiated voluntary U.S. recall of CGuard Prime 135cm carotid stent delivery system after determining technical success during procedures did not meet performance expectations during controlled launch. Recall affects delivery system only, not the stent implant itself.

  Item 7.01: Product Recall verify on EDGAR →
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  FDA approved Investigational Device Exemption (IDE) for CGUARDIANS III pivotal study testing SwitchGuard neuro protection system with CGuard Prime 80cm stent platform in TCAR procedures. Approval includes next-generation enhancements from prior IDE.

  Item 7.01: FDA Approval verify on EDGAR →
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  Two press releases issued May 1, 2026 under Regulation FD disclosure requirements to ensure fair dissemination of material information to all investors simultaneously.

  Item 7.01 verify on EDGAR →