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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00717-3
Product Name/Description Mirage, Silverspeed, X-celerator & X-pedion Guidewires, Hyperform & Hyperglide Occlusion Balloon Catheters and Guidewires (Supplied in Procedure Packs)
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 13/07/2012
Responsible Entity EV3 Australia Pty Limited
Reason/Issue There is a regulatory compliance issue where the guidewires were included in the Australian Register of Therapeutic Goods (ARTG) as Class IIa medical device. They should have been included as Class III. The Hyperform and Hyperglide Occlusion Balloon Catheters, which are currently supplied in
procedure packs also contain one of the above-mentioned guidewires. It has come to the attention of EV3 that these systems have not been included in the ARTG.
Recall Action Recall
Recall Action Instructions Quarantine affected stock. The use of affected microcatheters should be only limited to patients eligible under the Special Access Scheme.
Contact Information 1300 179 997 - ev3 Australia