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Medium risk Medical DevicesClass II

CGuard Prime Carotid Stent Recall

Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840

Updated May 1, 2026

The CGuard Prime Carotid Stent System (model CND0840) may encounter deployment complications that prevent the stent from being placed properly during the procedure. If you have received this stent or are scheduled for placement, contact your healthcare provider immediately.

Is the INSPIREMD Inc recalled? Yes. This product was recalled by FDA on May 1, 2026. Details below.

What is recalled

CGuard Prime Carotid Stent System, 135 cm, 8 mm x 40 mm, Model/Catalog Number CND0840, manufactured by InspireMD Inc.

Am I affected

You are affected if you have received or are scheduled to receive the CGuard Prime Carotid Stent System model CND0840 (8 mm x 40 mm, 135 cm length). Check with your healthcare provider if you underwent a carotid stent placement procedure.

What to do right now

If you have received this stent, contact your healthcare provider or the hospital where the procedure was performed immediately to discuss the potential deployment risk and any necessary follow-up care.

The hazard

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

Brands affected

INSPIREMD Inc
Source
FDA
Category
Medical Devices
Recall ID
fda-Z-2326-2026
Classification
Class II
Recalled
May 1, 2026
Read the official notice

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