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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00231-1
Product Name/Description	Archer 0.035 inch (0.89mm) Super Stiff Guidewire Model Number: ARCSJ260W Lot Number: GFWL0415 ARTG Number: 200043
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	13/03/2013
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use.
Recall Action	Recall
Recall Action Instructions	Customers are requested to immediately quarantine all affected units and contact Medtronic to initiate return and credit for the product.
Contact Information	02 9857 9000 - Medtronic Regulatory Affairs