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Medical Devices Sector
قطاع الأجهزة الطبية
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
mdprc 089 12 11 000
Cannulae, DLP® Single Stage Venous Cannulae
Those cannulae are intended for collection of venous blood from the right side of the heart via the superior or inferior vena cava during cardiopulmonary bypass surgery up to six hours or less.
Medical Device Identifier:
DLP® Single Stage Venous Cannulae
Reason of Field Safety Corrective Action:
Medtronic has received two reports of patient deaths due to product failure during use in ventricular assist procedures, which are outside the indications for use.
Medtronic is in the process of developing new instructions for the product. For the mean time, do not use this product for extended terms such as ventricular assist procedures.
Gulf Medical Co, Jeddah, (02) 6512828
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.