FDA-Device2026-06-17Class IIPROCESSING DEFECT
InspireMD CGuard Prime Carotid Stent System recalled for deployment complications
OTHERNationwide distribution
InspireMD CGuard Prime stent recalled for deployment risk
InspireMD's CGuard Prime Carotid Stent System (model CND0830, 8mm×30mm) may experience complications during deployment that could make it difficult or impossible to place the stent. About 190 units were distributed nationwide between February 2025 and February 2026. No injuries have been reported so far.
- If you received or implanted this stent, contact InspireMD or your healthcare provider immediately.
- Do not use affected units. Check the UDI number 07290120281691 and serial numbers from the affected date range.
- Healthcare facilities should quarantine and return affected inventory to the manufacturer.
Hazard
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
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
190 units
Manufactured in
6303 Waterford District Dr Ste 215, N/A, Miami, FL, United States
Products
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2325-2026More INSPIREMD Inc recalls
- FDA-Device2026-06-17InspireMD CGuard Prime Carotid Stent System recalled for deployment complications
- FDA-Device2026-06-17InspireMD CGuard Prime Carotid Stent System recalled for deployment complications
- FDA-Device2026-06-17INSPIREMD CGuard Prime Carotid Stent System recalled for deployment complications
- FDA-Device2026-06-17InspireMD CGuard Prime Carotid Stent System recalled for deployment complications
- FDA-Device2026-06-17InspireMD CGuard Prime Carotid Stent System recalled for deployment complications
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