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 CND1030, 10mm x 30mm) may be difficult or impossible to deploy during surgery due to complications in the delivery system. This affects 114 units manufactured between February 3 and February 23, 2026. No injuries have been reported.
- If you are a healthcare facility or physician with this stent in inventory, contact InspireMD Inc immediately for instructions.
- Do not use affected units (UDI 07290120281776) in patient procedures.
- Contact your medical device representative or the FDA if you have questions.
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
114 units
Manufactured in
6303 Waterford District Dr Ste 215, N/A, Miami, FL, United States
Products
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2329-2026Want us to check the next one for you?
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