Z-2328-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 17, 2026
- Initiation Date
- May 1, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 291 units
Product Description
Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
Reason for Recall
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.
Distribution Pattern
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.
Code Information
UDI: 07290120281745; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026