Recall Weekly
Moderate riskFDA DeviceClass II

InspireMD CGuard Prime Carotid Stent System recalled for deployment complications

The CGuard Prime Carotid Stent System (model CND0840, 8mm×40mm) may experience high resistance or fail to deploy properly during the placement procedure. This affects 424 units manufactured between early February 2025 and February 2026.

From the FDA notice · Read the official notice ↗

What to do

  1. If you received this stent or are scheduled to receive one, contact your healthcare provider immediately.
  2. Do not proceed with stent placement using an affected unit without consulting your doctor.
  3. Contact InspireMD for information on replacement or alternative options.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840
Sold in
Nationwide
Made for
Adults (0 months and older)

This recall covers 6 products — see all of them.

Details

Units affected
424 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-2326-2026

In the FDA's words

Description
Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840 Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. UDI: 07290120281707; 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: 424 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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