FDA DeviceClass IINotable

FDA Recall: Brand Name: CGuard Prime Carotid Stent System, 135cm, 9mx40mm Model/Catalog Number: CND0940

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

291 units

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