Inspiremd Inc: Stent, Carotid
CGuard Prime Carotid Stent System Recall Summary InspireMD Inc. is recalling the CGuard Prime Carotid Stent System (model CND0930, 9mm x 30mm, 135cm length) distributed nationwide because the stent delivery system may be difficult or impossible to deploy during surgery due to high resistance. This is a Class III recall, indicating a serious safety concern. The affected product was distributed across all U.S. states and the District of Columbia.
- Recalling firm
- INSPIREMD Inc
- Product
- CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
- 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/3a05332a-a8cf-4164-a401-bc67f47185f8