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 CND0840, 8mm×40mm) may experience high resistance or fail to deploy properly during the placement procedure. This affects 424 units manufactured between early February 2025 and February 2026.
- If you received this stent or are scheduled to receive one, contact your healthcare provider immediately.
- Do not proceed with stent placement using an affected unit without consulting your doctor.
- Contact InspireMD for information on replacement or alternative options.
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
424 units
Manufactured in
6303 Waterford District Dr Ste 215, N/A, Miami, FL, United States
Products
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2326-2026Want us to check the next one for you?
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