Inspiremd Inc: Stent, Carotid
Recall Summary InspireMD Inc. is recalling the CGuard Prime Carotid Stent System (model CND0840, 8mmx40mm, 135cm) distributed nationwide because the stent delivery system may experience high resistance or fail to deploy properly during the procedure. This is a Class III recall affecting a medical device used in carotid artery treatment.
- Recalling firm
- INSPIREMD Inc
- Product
- Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
- 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/22ee448f-f49a-4fcd-8009-cdf10324cf48