CGuard Prime Carotid Stent System Recall: Deployment Complications Risk

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Contact the company & request your remedy

Recalling firmINSPIREMD Inc6303 Waterford District Dr Ste 215, N/A · Miami, FL 33126-6004

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

INSPIREMD is recalling CGuard Prime Carotid Stent Systems that may have deployment complications. This could prevent proper stent placement during medical procedures, risking treatment failure.

Why it’s dangerous

The stent delivery system may face high resistance or fail to deploy the stent properly during medical procedures. This could lead to incomplete treatment or complications requiring additional interventions.

Who’s affected

Medical professionals using the CGuard Prime Carotid Stent System for carotid artery procedures. Patients receiving this stent system are at risk if the deployment fails.

How to tell if you have this one

Check for the model number CND0940 on the stent system. Units were manufactured between February 2025 and February 2026 with UDI 07290120281745.

Brand
CGuard Prime
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the model number CND0940 and manufacturing dates between February 2025 and February 2026.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall indicates potential deployment complications, so it is not recommended for use until the remedy is applied.

What should I do if I have this product?

The recall does not specify a remedy, so contact INSPIREMD for guidance on next steps.

How can I tell if I have the recalled product?

Check for model number CND0940 and manufacturing dates between February 2025 and February 2026.

Take action

Contact CGuard Prime

We’ve drafted a message you can send CGuard Prime to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-2328-2026 — CGuard Prime CGuard Prime

Hello,

I own a CGuard Prime that is covered by recall Z-2328-2026 from CGuard Prime.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2328-2026 (May 1, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2328-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

INSPIREMD Inc recalls Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940

Use caution until it’s fixed