INSPIREMD Inc — Class II: Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND
INSPIREMD Inc is conducting a Class II recall of the CGuard Prime Carotid Stent System (Model CND0840) due to potential complications during deployment where the system may encounter high resistance or fail to deploy.
This affects INSPIREMD Inc, healthcare providers utilizing the CGuard Prime Carotid Stent System, and regulatory/QA professionals overseeing implantable vascular device compliance.
The inability to deploy a carotid stent or encountering high resistance during a procedure introduces significant procedural risks. This suggests potential issues in the mechanical design or manufacturing consistency of the delivery system, necessitating a review of CAPA procedures for catheter-based delivery mechanisms.
Quality and engineering teams should review manufacturing specifications and deployment testing protocols for stent delivery systems. Regulatory and clinical teams must ensure field safety notices reach relevant clinical staff to prevent force-related complications during deployment.
Class II. Reason: Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent.. Product: Brand Name: CGuard¿ Prime Carotid Stent System, 135cm, 8mmx40mm Model/Catalog Number: CND0840. Firm: INSPIREMD Inc (Miami FL United States). Status: Ongoing.
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