Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: 07290120281707; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- INSPIREMD Inc
- Reason for Recall:
- Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
Product Codes/Lot Numbers:
UDI: 07290120281707; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2326-2026
Related Recalls
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
INSPIREMD
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.