Inspiremd Inc: Stent, Carotid
Recall Summary InspireMD Inc. is recalling the CGuard Prime Carotid Stent System (model CND0830, 8mmx30mm size) because the stent delivery system may be difficult or impossible to deploy during placement, potentially causing complications. The affected stent was distributed nationwide across the United States. This is a Class III recall, indicating a serious safety issue.
- Recalling firm
- INSPIREMD Inc
- Product
- Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
- 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/eb4792b0-5bf2-4c07-93a6-7acb1eaa48b4