FDA DeviceClass IINotable

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

Date: 2026-06-17
Brand: INSPIREMD Inc
Category: Medical Device
FDA Class: Class II

Description

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

Hazard

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

Remedy

190 units

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