Recall Weekly
Moderate riskFDA DeviceClass II

InspireMD CGuard Prime Carotid Stent System recalled for deployment complications

The CGuard Prime Carotid Stent System (model CND0930, 135cm) may experience complications during deployment that could result in high resistance or inability to place the stent. This affects 147 units manufactured between February 3, 2025 and February 23, 2026, distributed nationwide.

From the FDA notice · Read the official notice ↗

What to do

  1. If you have received or implanted this stent, contact InspireMD or your physician immediately with the lot or serial number
  2. Check the device UDI (07290120281738) to confirm if your unit is affected
  3. Do not use affected units for new procedures
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 6 products — see all of them.

Details

Units affected
147 units
Illnesses reported
None reported
Manufactured in
6303 Waterford District Dr Ste 215, N/A, Miami, FL, United States
Classification
Class II
Recall number
Z-2327-2026

In the FDA's words

Description
CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930 Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. UDI: 07290120281738; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026 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. Affected quantity: 147 units
Hazard
Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

6 products in this recall

InspireMD CGuard Prime carotid stent systems recalled for deployment risk

InspireMD is recalling six sizes of its CGuard Prime Carotid Stent System, covering 1,377 units in total. The stent delivery system may run into complications during deployment, which can cause high resistance or prevent the stent from being deployed. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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