FDA DeviceClass IINotable

FDA Recall: CGuard Prime Carotid Stent System, 135cm, 10mmx30mm Model/Catalog Number: CND1030

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

114 units

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