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Brand Name: CGuard Prime Carotid Stent System, 135cm… recallZ-2325-2026 · INSPIREMD Inc · initiated May 1, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from INSPIREMD Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.

FDA root cause category: Component design/selection

What the company is doing

On May 1, 2026, InspireMD, Inc. issued a Urgent Medical Device Recall notification to affected consignees. InspireMD asked consignees to take the following actions: 1. Cease further use of all affected CGuard Prime Carotid Stent Systems identified by the model numbers listed in the letter. 2. Quarantine and segregate all affected units currently in your inventory. Place affected product in a clearly labeled quarantine area to prevent inadvertent use. 3. This notice needs to be passed on to all those who need to be aware within your organization or facilities where the affected devices have been transferred. 4. Please retain a copy of this letter, and keep a copy of the Acknowledgement Form. 5. Complete the attached Acknowledgement Form and return it by email to [email protected] within 2 business days. 6. InspireMD will contact each affected customer to facilitate the return and disposition process.

Recall details

Recall number
Z-2325-2026
Status
Open, Classified
Initiated by the company
May 1, 2026
Posted by the FDA
Jun 5, 2026
Recalling firm
INSPIREMD Inc
Quantity
190 units
Product code
NIM
FDA submissions
P240029
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.

Product description

Brand Name: CGuard Prime Carotid Stent System, 135cm, 8mmx30mm Model/Catalog Number: CND0830

Code information (models, lots, serial numbers)

UDI: 07290120281691; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

5 devices cleared under P240029 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 98922).

Sources and updates

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