CGuard Prime Carotid Stent System Recall: Deployment Complications Risk

Take action

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 (model CND0840) because the delivery system might have trouble deploying the stent, which could cause high resistance or failure. This is a medical device used in carotid artery procedures, so it matters for patient safety during surgery.

Why it’s dangerous

The stent delivery system might not deploy the stent properly during surgery, causing high resistance or inability to place the stent. This could lead to complications like failed procedures or additional medical risks for the patient.

Who’s affected

Patients undergoing carotid artery procedures who received this specific stent system model between February 2025 and February 2026 are likely affected. Medical professionals using the device for procedures are at risk if they have the recalled model.

How to tell if you have this one

Check for the model number CND0840 on the device packaging or label. The product was sold between February 2025 and February 2026 with the unique identifier UDI: 07290120281707.

Brand
CGuard Prime
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Look for the model number CND0840 and the unique identifier UDI: 07290120281707 on the device packaging or label.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall record states the stent delivery system may encounter deployment complications, so it is not safe to use without the remedy.

What should I do if I have this product?

The recall record does not specify a remedy, so contact INSPIREMD for guidance.

When was this product sold?

The product was sold 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-2326-2026 — CGuard Prime CGuard Prime

Hello,

I own a CGuard Prime that is covered by recall Z-2326-2026 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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-2326-2026 (May 1, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2326-2026 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, 8mmx40mm Model/Catalog Number: CND0840

Recall notice