Print version of this report
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 EV3 Australia Pty Limited
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