Recall Weekly
Moderate riskFDA DeviceClass II

INSPIREMD CGuard Prime Carotid Stent System recalled for deployment complications

The CGuard Prime Carotid Stent System (model CND1040, 10mm×40mm) may encounter complications during deployment, including high resistance or inability to deploy the stent properly. This affects 211 units manufactured between February 3 and February 23, 2026, distributed across the United States.

From the FDA notice · Read the official notice ↗

What to do

  1. If you received or implanted this stent, contact INSPIREMD Inc immediately for guidance.
  2. Do not use affected units if they have not yet been implanted.
  3. Healthcare facilities should verify stent lot/serial numbers against the affected date range and UDI 07290120281783.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 6 products — see all of them.

Details

Units affected
211 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-2330-2026

In the FDA's words

Description
CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040 Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. UDI: 07290120281783; 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: 211 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