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Get filing alertsInspireMD 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 →
Summary
InspireMD disclosed two significant developments on May 1, 2026. The company initiated a voluntary recall of its CGuard Prime 135cm carotid stent delivery system in the United States after the device failed to meet performance expectations during a controlled launch. Importantly, the recall is limited to the 135cm delivery system—the actual CGuard stent implant is not affected.
This setback impacts one product variant but does not appear to affect the company's broader product portfolio. Balancing this negative news, InspireMD announced FDA approval to proceed with the CGUARDIANS III pivotal study. This approval allows the company to test its SwitchGuard neuro protection system with the CGuard Prime 80cm stent platform in transcarotid artery revascularization procedures.
The IDE approval includes next-generation enhancements and represents a critical step toward potential future regulatory clearance for commercial use. Retail investors should monitor two things: first, whether the 135cm delivery system issues affect sales or require additional remediation costs; second, enrollment progress and timeline for the CGUARDIANS III study, as successful completion could open significant market opportunities.
Section-by-Section Diff
Event · Item 7.01 — Regulation FD Disclosure
InspireMD issued press releases on May 1, 2026, under Regulation FD disclosure; specific event details not provided in filing excerpt.
Show 1 minor / wording change
Added in current filing · verify on EDGAR →
On May 1, 2026, InspireMD, Inc. (the “Company”) issued press releases announcing the events described in
The company made a Regulation FD disclosure on May 1, 2026, by issuing press releases. The filing excerpt is incomplete and does not specify what events were announced in the press releases. Regulation FD disclosures typically involve material non-public information being shared publicly to ensure fair disclosure to all investors.
Event · Item 8.01 — Other Events
Item 8.01 — Other Events filed; see Key Changes for terms.
Added in current filing · verify on EDGAR →
the Company announced that it initiated a voluntary recall in the United States of its CGuard® Prime 135 cm carotid stent delivery system after determining during a controlled launch that the technical success of the delivery system during carotid artery stenting (“CAS”) procedures has not met performance expectations.
InspireMD is recalling its CGuard Prime 135 cm carotid stent delivery system in the U.S. because the device did not perform as expected during procedures. The recall is limited to the 135 cm delivery system and does not affect the CGuard stent implant itself. This was discovered during a controlled product launch.
Event · Item 9.01 — Financial Statements and Exhibits
InspireMD filed an 8-K attaching two press releases dated May 1, 2026; no material event details disclosed in the filing body itself.
Added in current filing · verify on EDGAR →
99.1 | Press Release, dated May 1, 2026 | 99.2 | Press Release, dated May 1, 2026
The 8-K lists two press releases dated May 1, 2026 as exhibits but provides no substantive disclosure in the filing body. The nature and content of the announcements are not described, so investors must review the attached exhibits to understand what was disclosed.
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Figures/quotes linked to EDGAR · Narrative written by AI · Jun 2, 2026 · How we verify