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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