Serious health risk
⚠ This recall is currently active
INSPIREMD Inc
Devices recall · Z-2326-2026
Reason for recall
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Product description
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
Recalling firm
INSPIREMD Inc
Product quantity
424 units
Lot / code info
UDI: 07290120281707; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
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.
Recall initiated
2026-05-01
Status
Ongoing
Location
Miami, FL, United States
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Data from official federal safety records. Updated periodically. Verify on FDA.gov