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 Impella 5.5 with SmartAssist heart pumps [Item code: 0550-0007; Serial numbers: 425332, 463954, 425331, 425570] [HKMD No.: 210382].
According to the TGA, there is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This can result in low flow from the damaged Impella system.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2023-RN-00834-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 27 Sep 2023