FDA DeviceClass IINotable

FDA Recall: CGuard¿ Prime Carotid Stent System, 135cm, 10mmx40mm Model/Catalog Number: CND1040

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

211 units

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