Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning William A. Cook Australia, Pty. Ltd. 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] [HKMD No.: 090263]
According to the TGA, the manufacturer 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. 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.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2023-RN-00162-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 1 Mar 2023