INSPIREMD Inc recalls CGuard¿ Prime Carotid Stent System

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040

On May 1, 2026, InspireMD, Inc. issued a Urgent Medical Device Recall notification to affected consignees. InspireMD asked consignees to take the following actions: 1. Cease further use of all affected CGuard Prime Carotid Stent Systems identified by the model numbers listed in the letter. 2. Quarantine and segregate all affected units currently in your inventory. Place affected product in a clearly labeled quarantine area to prevent inadvertent use. 3. This notice needs to be passed on to all those who need to be aware within your organization or facilities where the affected devices have been transferred. 4. Please retain a copy of this letter, and keep a copy of the Acknowledgement Form. 5. Complete the attached Acknowledgement Form and return it by email to USSupport@inspiremd.com within 2 business days. 6. InspireMD will contact each affected customer to facilitate the return and disposition process.

• FDA enforcement recordOfficial FDA database entry for Z-2330-2026
• FDA device classification · NIMOfficial FDA classification for this device type
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find INSPIREMD IncSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.