FDA recall Z-2329-2026

INSPIREMD Inc · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2026-05-01
Report date
2026-06-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Miami, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2329-2026