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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-00162-1
Product Name/Description	Zenith Branch Endovascular Graft - Iliac Bifurcation (ZBIS) Part Number: ZBIS-10-45-41, ZBIS-10-45-58, ZBIS-10-61-58, ZBIS-12-45-41, ZBIS-12-45-58, ZBIS-12-61-41, ZBIS-12-61-58 Order Number: G38612, G38613, G38615, G38616, G38617, G38618, G38344 All lot numbers ARTG 138930 (William A Cook Australia Pty Ltd - Zenith Branch Endovascular Graft - Iliac Bifurcation - Graft, vascular, synthetic)
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	27/02/2023
Responsible Entity	William A Cook Australia Pty Ltd
Reason/Issue	Cook Medical has received reports that the tip of the catheter, which is an indwelling component of the ZBIS device is splitting/breaking during device preparation or during the endovascular procedure. To date, Cook Medical has not received reports of irreversible outcomes to patients. The catheter tip is radiopaque and visible under fluoroscopy which enables medical intervention by endovascular methods or open access in situations where the tip breaks during the procedure.
Recall Action	Product Defect Alert
Recall Action Instructions	William A Cook advise that customers may continue to use these devices, after taking into consideration: Prior to using the ZBIS, inspect the catheter tip for damage. The catheter tip is exposed allowing for inspection during device preparation before the procedure. If there is visible damage, do not use the device. WCA recommends not using the product if its shelf life is greater than 2 years. Customers should examine their inventory for affected products and display the PDA prominently until the product recall is initiated once a replacement catheter tip becomes available. This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information	1800 777 222 - Cook Medical Customer Relations