SFDA National Center for Medical Devices Reporting

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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 089 12 11 000
Date submitted:	12/21/2011

Manufacturer:	Medtronic Inc
Device Type:	Cannulae, DLP® Single Stage Venous Cannulae
Description:	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.
Remedy Action:	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.
Athorized Representative/Importer/Distributor:	Gulf Medical Co, Jeddah, (02) 6512828
Report Source:	NCMDR
Source Ref. Number:	DD3670908F2A2
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Medtronic.pdf

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