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

FDA device recall Z-2329-2026 · posted 2026-06-05 · Open, Classified

Recall details

Recalling firm

INSPIREMD Inc

Reason for recall

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

Action taken

On May 1, 2026, InspireMD, Inc. issued a Urgent Medical Device Recall notification to affected consignees. InspireMD asked consignees to take the following actions: 1. Cease further use of all affected CGuard Prime Carotid Stent Systems identified by the model numbers listed in the letter. 2. Quarantine and segregate all affected units currently in your inventory. Place affected product in a clearly labeled quarantine area to prevent inadvertent use. 3. This notice needs to be passed on to all those who need to be aware within your organization or facilities where the affected devices have been transferred. 4. Please retain a copy of this letter, and keep a copy of the Acknowledgement Form. 5. Complete the attached Acknowledgement Form and return it by email to USSupport@inspiremd.com within 2 business days. 6. InspireMD will contact each affected customer to facilitate the return and disposition process.

Root cause

Component design/selection

Status

Open, Classified

Product code

NIM

Quantity affected

114 units

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.

Date initiated

2026-05-01

Date posted

2026-06-05

Location

Miami, FL