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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 047 05 13 000
Date submitted: 5/13/2013
Manufacturer:Medtronic..
Device Type:Nerve monitoring products . NIM Flex, EMG Endotracheal Tube
Description:Nerve monitoring products can be used in conjunction with NIM Nerve Monitoring Systems during a variety of surgical procedures
Medical Device Identifier:REF # 8229960, 8229965, 8229970, 8229975, 8229980, 8229985 Lot # see Attachment
Reason of Field Safety Corrective Action:The tubes that used to manufacture the NIM Flex™ Endotracheal Tube product, may have the potential to delaminate. Investigation has shown that such delamination can result in herniation of the inner lumen when the cuffs are over-inflated. Such herniation can constrict the inner lumen of the endotracheal tube resulting in a reduction of airflow to the patient.
Remedy Action:Check your inventories for the affected products. and If you have any of the subject product, contact Medtronic ENT Customer Service at AL FAISALIAH MEDICAL SYSTEMS LTD. at +966 1 211 4607 and Sales Representative will be contacting you to facilitate the return of any affected NIM Flex™ EMG Endotracheal Tube you may have.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System, Riyadh, ( 011 ) 2119948
Report Source:NCMDR
Source Ref. Number:A0E0650814201
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic.pdf