CGuard Prime Carotid Stent System recall
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
Why was CGuard Prime Carotid Stent System recalled?
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 07290120281776; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
- Product
- CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
- Recalling firm
- INSPIREMD Inc
- Quantity
- 114 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.
- Recall date
- June 17, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)