Class II U.S. Food and Drug Administration

INSPIREMD Inc Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx30mm Model/ recall: Stent delivery system may encounter complications during deployment

Recall published 4 months ago

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

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

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

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-2325-2026
Published
June 17, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
INSPIREMD Inc
Product type
Medical devices
Units affected
190 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI: 07290120281691; all lots/serial numbers manufactured between 02/03/2025 and 02/23/2026
UPC codes
07290120281691

Products covered by this recall

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

Check your product

The notice names 12 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 07290120281691

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 03
  • 2025
  • 02
  • 23
  • 2026 — 190 u

Model or item number

On the rating label, the box or the instruction sheet.

  • CND0830 — UDI

Serial number

On the rating plate, often next to the date of manufacture.

  • manufactured between 02
  • 03
  • 2025
  • 02
  • 23

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

INSPIREMD Inc — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: INSPIREMD Inc — 6303 Waterford District Dr Ste 215, Miami, FL, 33126-6004

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was INSPIREMD Inc medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 07290120281691; lot code 03, 2025, 02; model number CND0830 — UDI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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