| 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 |
|
| 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 |