Inspiremd Inc: Stent, Carotid
Recall Summary INSPIREMD Inc is recalling the CGuard Prime Carotid Stent System (model CND1040, 10mmx40mm, 135cm length) distributed nationwide. The stent delivery system may experience high resistance or fail to deploy properly during the procedure. This is a Class III recall affecting patients who received or may receive this specific stent model.
- Recalling firm
- INSPIREMD Inc
- Product
- CGuard Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
- Reason
- Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-01
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/438ef5e4-04ca-4a75-adad-7799f7f9ce18