INSPIREMD CGuard Prime Carotid Stent System Recall: Deployment Complications Risk

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

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✎ GovInfoNow plain-language explainer

What happened, in plain English

INSPIREMD is recalling its CGuard Prime Carotid Stent System (model CND1030) because it may have deployment issues that could cause high resistance or failure to deploy the stent. This could lead to medical complications during procedures.

Why it’s dangerous

The stent delivery system may face complications during deployment, causing high resistance or inability to deploy the stent. This could lead to medical complications during the procedure, such as vessel damage or incomplete treatment.

Who’s affected

Medical professionals using the CGuard Prime Carotid Stent System for carotid artery procedures are affected. Patients undergoing such procedures with this specific model are at risk.

How to tell if you have this one

Check for the model number CND1030 on the product. Units were manufactured between February 2025 and February 2026 with UDI 07290120281776.

Brand
INSPIREMD
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the model number CND1030 and check the 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 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 instructions.

When was this product manufactured?

Units were manufactured between February 2025 and February 2026.

Take action

Contact INSPIREMD

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

✉️ Open in email

Subject: Recall Z-2329-2026 — INSPIREMD INSPIREMD

Hello,

I own a INSPIREMD that is covered by recall Z-2329-2026 from INSPIREMD.

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-2329-2026 (May 1, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2329-2026 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 CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030

Recall notice