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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-00861-1
Product Name/Description Multiple AxiEM ENT Suction Instruments

Straight Suction EM, ENT
Curved Suction 70 EM,
Short Curved Suction 90, EM
Suction Small Straight AxiEM ENT

Multiple Part and Lot Numbers

These instruments may also be included in the following kits:

ENT Instrument Set
Fusion ENT Instrument Kit
ENT AxiEM Instrument Set
ENT Prgm Add Fusion Nav AxiEM

ARTG Numbers: 129428, 125074 & 120114
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 12/07/2017
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue Medtronic has become aware that the specific lots of AxiEM 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 StealthStation.

If this issue presents during surgery, it may result in surgery being extended to troubleshoot the issue, discontinuation of navigation, or aborting surgery if alternative instruments are not available to proceed. To date, there have been no reports of patient injury.
Recall Action Recall
Recall Action Instructions Medtronic is requesting customers examine their inventory and if any of the affected products listed in the customer letter are found, immediately cease use and quarantine them for return to Medtronic. Alternatively, each local Medtronic Sales Representative will perform this step. If the product has been removed from its original packaging, the part number and lot number can be found printed directly on the device as shown in the pictures given in the customer letter.

This action has been closed out on 26/02/2019
Contact Information 02 9857 9000 - Medtronic