Recall Weekly
Moderate riskFDA DeviceClass II

InspireMD CGuard Prime Carotid Stent System recalled for deployment complications

The CGuard Prime Carotid Stent System (model CND0940, 9mm × 40mm, 135cm length) may experience difficulty during placement in the artery. The delivery system could encounter high resistance or fail to deploy the stent properly.

From the FDA notice · Read the official notice ↗

What to do

  1. If you received this stent model, contact your physician or hospital immediately.
  2. Do not use the stent if it has not yet been implanted.
  3. Report any deployment problems or patient complications to InspireMD and the FDA.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 6 products — see all of them.

Details

Units affected
291 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-2328-2026

In the FDA's words

Description
Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940 Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. UDI: 07290120281745; 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: 291 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.

Related topics

OtherMedical devicesSold nationwideMore from FDA Device