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 Administration (TGA) has posted a medical device safety alert concerning Boston Scientific Corporation Autotome RX (20mm CUT WIRE) Cannulating Sphincterotome [Material number: M00545170] [HKMD No.:110410].
According to the TGA, Boston Scientific is initiating a removal of one lot of Autotome RX Cannulating Sphincterotomes due to reports of the presence of foreign material on the enclosed section of the cutting wire, between the handle and the distal end of the device which may lead to inability to optimally bow the sphincterotome.
For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00477-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 Jun 2024