| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2012-RN-00704-3 |
| Product Name/Description |
Onyx Liquid Embolic System (LES), (Used for embolization of intracranial aneurysms and lesions in the peripheral and neurovasculature).
Model number(s):105-7000-060/65/80; 105-7200-060/80; 105-8300-500
All Lot numbers affected
ARTG Number: 151837 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
27/07/2012 |
| Responsible Entity |
|
| Reason/Issue |
EV3 have issued update to the Instructions For Use (IFU) to inform physicians and patients about the risk of catheter entrapment associated with the use of Onyx Liquid Embolic System (LES) |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Updated Instructions for Use (IFU) is being provided to the customers. |
| Contact Information |
0422 656 311 - Kirk Slater |