Class II — INSPIREMD Inc
| Recalling firm | InspireMD, Ltd. |
|---|---|
| Registered facility | INSPIREMD, LTD. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. |
| Product | CGuard® Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040 |
| Quantity | 211 units |
| Distribution | US Nationwide distribution in the states of AR, AZ, CA, DC, FL, GA, HI, IL, IN, KS, MA, MD, MI, MO, NC, NJ, NV, NY, OH, OR, RI, SD, TN, TX, VA, WA, WI, WV. |
| Initiated | 2026-05-01 |
| Classified | 2026-06-05 |
| Recall number | Z-2330-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — INSPIREMD Inc (Z-2330-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98922/
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