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

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

✎ GovInfoNow plain-language explainer

What happened, in plain English

INSPIREMD is recalling its CGuard Prime Carotid Stent System (model CND0930) because the stent delivery system may have trouble deploying the stent, potentially causing high resistance or failure. This could lead to complications during medical procedures.

Why it’s dangerous

The stent delivery system might not deploy the stent properly during medical procedures, causing high resistance or inability to deploy. This could lead to complications like tissue damage or procedure failure.

Who’s affected

Patients undergoing carotid stent procedures who use the CGuard Prime system with model number CND0930 are affected. Medical professionals performing the procedure are most at risk.

How to tell if you have this one

Check for the model number CND0930 on the stent system. Units were manufactured between February 3, 2025, and February 23, 2026.

Brand
INSPIREMD
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Contact Manufacturer
Reach out to INSPIREMD for specific instructions on how to handle the recalled product.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The recall indicates potential deployment complications, so it is not safe to use without manufacturer guidance.

What should I do if I have this product?

Contact INSPIREMD directly for instructions on handling the recalled product.

When was this product manufactured?

Units were manufactured between February 3, 2025, and February 23, 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-2327-2026 — INSPIREMD INSPIREMD

Hello,

I own a INSPIREMD that is covered by recall Z-2327-2026 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-2327-2026 (May 1, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2327-2026 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, 9mx30mm Model/Catalog Number: CND0930

Use caution until it’s fixed