FDA-Device2026-06-17Class IIPROCESSING DEFECT
INSPIREMD CGuard Prime Carotid Stent System recalled for deployment complications
What this means
The CGuard Prime Carotid Stent System (model CND1040, 10mm×40mm) may encounter complications during deployment, including high resistance or inability to deploy the stent properly. This affects 211 units manufactured between February 3 and February 23, 2026, distributed across the United States.
- If you received or implanted this stent, contact INSPIREMD Inc immediately for guidance.
- Do not use affected units if they have not yet been implanted.
- Healthcare facilities should verify stent lot/serial numbers against the affected date range and UDI 07290120281783.
The agency's original wording
Hazard
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
211 units
Manufactured in
6303 Waterford District Dr Ste 215, N/A, Miami, FL, United States
Products
CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2330-2026Want us to check the next one for you?
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