Class II

Medical Device Recall: CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030

INSPIREMD Inc · May 1, 2026

Reason for Recall

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

114 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2329-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

INSPIREMD Inc Medical Device Recall: CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030 | SafeCheck