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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 005 07 17 000
Date submitted: 7/3/2017
Manufacturer:Medtronic
Device Type:AxiEMTM ENT Suction instruments
Description:Suction instruments
Medical Device Identifier:Part Numbers:
- 9733449 Straight Suction EM, ENT
- 9733450 Curved Suction 70, EM
- 9733451 Short Curved Suction 90, EM
- 9734308 Suction Small AxiEMTM ENT

See Attached FSN for full list
Reason of Field Safety Corrective Action:Medtronic has become aware that specific lots of AxiEMTM ENT Suction instruments are not able to pass instrument verification. Instrument verification is a step in the software which is performed prior to the use of each instrument. This verification step confirms device tracking functionality and prevents use of the device if a passing verification is not achieved. The impacted devices were made with a particular stainless steel stock material that exhibits magnetic characteristics (magnetic permeability), causing interference with electromagnetic (EM) tracking capability of the StealthStationTM.
Remedy Action:1. Immediately identify and quarantine all affected product in your inventory. If the product has been removed from its original packaging, the part number and lot number can be found printed directly on the device.
2. Return all affected product in your inventory to Medtronic. Your Medtronic Representative will assist you in the return and replacement of this product as necessary.
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR
Source Ref. Number:2BF28639111ED
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic (2).pdf