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INSPIREMD Inc recalls Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
Recalled June 17, 2026 · FDA recall Z-2328-2026 · INSPIREMD
Hazard
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. · FDA Class II
Units
291 units
Sold at
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.
Description
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Product
Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
Manufacturer(s)
INSPIREMD Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →