Recalling firm
INSPIREMD Inc
Product type
Device
Status
Ongoing
Report date
2026-06-17
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.
Firm state
FL
Product quantity
211 units
Initiated by
Voluntary: Firm initiated
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
CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
Code / lot info
UDI: 07290120281783; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.