Inspiremd Inc: Stent, Carotid
CGuard Prime Carotid Stent System Recall INSPIREMD Inc is recalling the CGuard Prime Carotid Stent System (model CND1030, 10mmx30mm, 135cm length) distributed nationwide because the stent delivery system may be difficult or impossible to deploy during the procedure due to high resistance. This is a Class III recall affecting patients who received this device for carotid artery treatment.
- Recalling firm
- INSPIREMD Inc
- Product
- CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
- 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/ad61f01f-86d0-488f-9026-d5c92acc4bcf