FDA DeviceClass IINotable

FDA Recall: CGuard Prime Carotid Stent System, 135cm, 9mx30mm Model/Catalog Number: CND0930

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

147 units

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