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 CND0930, 135cm) may experience complications during deployment that could result in high resistance or inability to place the stent. This affects 147 units manufactured between February 3, 2025 and February 23, 2026, distributed nationwide.
- If you have received or implanted this stent, contact InspireMD or your physician immediately with the lot or serial number
- Check the device UDI (07290120281738) to confirm if your unit is affected
- Do not use affected units for new procedures
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
147 units
Manufactured in
6303 Waterford District Dr Ste 215, N/A, Miami, FL, United States
Products
CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2327-2026Want us to check the next one for you?
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