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 Medtronic Inc. Abre Venous Self-expanding Stent System [Product Number: AB9G14100090; Serial Number/Batch: B460542; Product GTIN: 00763000547325] [HKMD number: 190291].
According to the TGA, the manufacturer is initiating a product recall for specific impacted lots of the Abre Venous Self-expanding Stent System due to the potential for sterile package breach.
For further information, please visit https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2024-RN-00127-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 19 Feb 2024