{"url_path":"/fda/device/recalls/Z-2327-2026","section_key":"summary","section_title":"DEVICE Recall: INSPIREMD Inc — CGuard Prime Carotid Stent System,  135cm, 9mx30mm  Model/Catalog Number: CND0930","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-01","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2327-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"INSPIREMD Inc"},"word_count":107,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2327-2026\n\n**Recalling firm:** INSPIREMD Inc\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-01\n**Report date:** 2026-06-17\n\n## Product\nCGuard Prime Carotid Stent System,  135cm, 9mx30mm  Model/Catalog Number: CND0930\n\n## Reason\nStent delivery system may encounter complications during deployment which may result in high resistance  or inability to deploy the stent.\n\n## Affected lots\nUDI: 07290120281738; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026\n\n## Distribution\nUS 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."}