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 CND0940, 9mm × 40mm, 135cm length) may experience difficulty during placement in the artery. The delivery system could encounter high resistance or fail to deploy the stent properly.
- If you received this stent model, contact your physician or hospital immediately.
- Do not use the stent if it has not yet been implanted.
- Report any deployment problems or patient complications to InspireMD and the FDA.
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
291 units
Manufactured in
6303 Waterford District Dr Ste 215, N/A, Miami, FL, United States
Products
Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2328-2026Want us to check the next one for you?
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