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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 086 11 17 001
Cordis S.M.A.R.T.® Flex Vascular Stent System.
Flex Vascular Stent System
Medical Device Identifier:
85 lot numbers of 48 catalog numbers. Reference Table 1. The lot number range is from 40932 through 41637, but not all lots in the range are affected.
NCMDR Update Code:
GTIN: Catalog No.
Multiple Lot numbers of the affected device are provided in the attached FSN
Reason of Field Safety Corrective Action:
Based on one complaint and the subsequent investigation, Cordis has determined that 85 distributed lots of S.M.A.R.T.® Flex Vascular Stent System have a potential for cracked luer hubs, due to a manufacturing error.
The luer hub is used to inject contrast/saline during procedure preparation, prior to insertion of the stent system into the patient. A cracked hub could result in leakage of saline, or in the worst case, inability to flush the outer sheath of the catheter.
Check your inventory to determine if you have any remaining affected product in your possession. Check all storage and usage locations. The purpose is to identify the product, not to remove the product.
During procedure preparation, check for cracks/leaks. If the user detects a crack prior to flushing, or a leak during flushing, select a replacement device. (See inspection section below.) Report the incident through the standard complaint process.
ABDULREHMAN AL GOSAIBI GTB
Source Ref. Number:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Copyright © 2008 Saudi Food and Drug Authority. All rights reserved.