Z-2328-2026 Class II Ongoing
FDA device recall Z-2328-2026 was initiated by INSPIREMD Inc on May 1, 2026 and is designated Class II. Reason for recall: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. The recall status is ongoing. Affected quantity: 291 units.
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