| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00867-3 |
| Product Name/Description |
Protege EverFlex Self-Expanding Peripheral Stent System containing all size variants of 5mm diameter stent in both 80cm and 120cm delivery catheters. Protege EverFlex Self-Expanding Peripheral Stent System containing all size variants of 200mm length stent in 6, 7, 8mm diameter stent in 120cm delivery catheters. (Vascular prosthetic stent)
Multiple Product Codes |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
28/08/2012 |
| Responsible Entity |
|
| Reason/Issue |
Ev3 has identified a regulatory compliance issue with the Protege EverFlex Self-Expanding Peripheral Stent System range of products. The majority of these products were included in the Australian Register of Therapeutic Goods under ARTG 151132. However, the additional sizes with the smallest diameter stent of 5mm and the 6-8mm stents of greatest length of 200mm were inadvertently released prior to the TGA's review and approval for inclusion under ARTG 151132. |
| Recall Action |
Recall |
| Recall Action Instructions |
EV3 Australia is asking hospitals to quarantine the affected stent system in a controlled area. Ev3 is advising clinicians that availability of the affected stent system is limited to patients eligible under the Special Access Scheme. Alternatively, individual clinicians can apply to the TGA to become an Authorised Prescriber. |
| Contact Information |
1300 179 997 - ev3 Australia |