FDAFDA · Food and drugs·Recall number Z-2328-2026
Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
Published June 17, 2026 · Recall initiated: May 1, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- INSPIREMD Inc
- Distributor
- 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.
- Lot
- UDI: 07290120281745; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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