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Medical Devices Sector
قطاع الأجهزة الطبية
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 047 03 17 001
Date submitted: 10/21/2018
Device Type: StrataMR™ Adjustable Valves & Shunts
Description:Valves, shunts
Medical Device Identifier:Model numbers: 42955, 42965, 45905, 46955, 46960, 46965, and 46970
Reason of Field Safety Corrective Action:Medtronic is initiating this voluntary recall because the products identified above may experience a condition that may, in limited circumstances, affect the flow resistance in the valve and result in underdrainage of cerebrospinal fluid (CSF). The condition can occur when the valve mechanism is adjusted to a position that causes a higher than intended flow resistance.
Remedy Action:Return all affected products to the manufacturer


TGA Update Action:

For implanted devices, a fourth component, the Guider Tool is being added to the StrataMR Adjustment Tool Set in order to improve users’ ability to reliably adjust StrataMR valves. Proper use of the Guider tool will further mitigate the potential risk of the valve rotor foot being positioned on top of the MRI resistance wall during the adjustment process. There is no change to the design of the existing three tools of the StrataMR adjustment tool sets.

Medtronic is advising customers that a sales rep will arrange conversion of the StrataMR Guider Tool to the existing tool set and provide brief instructions on its use (including revision of IFU updates).
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR, TGA
Source Ref. Number:2545F7B2A52B8, RC-2018-RN-01378-1
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:No Attachments