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.
Medical device manufacturer, Atrium Medical Corporation, has issued a medical device safety alert concerning its Advanta VXT and Flixene Vascular Grafts [HKMD No.:090261].
According to the manufacturer, between 27 December 2023 and 17 April 2024, Atrium Medical Corporation/Getinge received eight (8) complaints reporting that the Slider GDS Swivel Rod separated from the Slider GDS Swivel Core, and three (3) complaints that reported a notable gap between the Slider GDS Swivel Rod and the Slider GDS Anchor (See Figure 1 and 2), which triggered this voluntary Medical Device Removal. In total, there have been 12 complaints related to this issue in the last three years (the product’s shelf life). There have been reports of prolonged procedures. In some cases, additional medical interventions were performed such as completing passage of the graft with forceps (3 cases), passing of a new graft through the pre-existing tunnel (5 cases), and using fluoroscopy to confirm GDS components were not present (1 case).
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 14 May 2024