Recall Weekly
Moderate riskFDA DeviceClass II

InspireMD CGuard Prime Carotid Stent System recalled for deployment complications

The CGuard Prime Carotid Stent System (model CND1030, 10mm x 30mm) may be difficult or impossible to deploy during surgery due to complications in the delivery system. This affects 114 units manufactured between February 3 and February 23, 2026. No injuries have been reported.

From the FDA notice · Read the official notice ↗

What to do

  1. If you are a healthcare facility or physician with this stent in inventory, contact InspireMD Inc immediately for instructions.
  2. Do not use affected units (UDI 07290120281776) in patient procedures.
  3. Contact your medical device representative or the FDA if you have questions.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

This recall covers 6 products — see all of them.

Details

Units affected
114 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-2329-2026

In the FDA's words

Description
CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030 Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. UDI: 07290120281776; 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: 114 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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