Print version of this report

TGA Action ID	RC-2026-RN-00348-1
Type of Product	Medical Device
Product Name/Description	SX-ELLA Stent Danis Procedure Pack – Basic Lot Numbers: P26020188-01, P25070098-02, P24110133-01, P24020206-01, P25100030-01, P25070098-01, P24030195-01, P23110026-01, P25090097-02, P25050019-01, P24010127-02, P23100089-01, P25090097-01, P25050019-02, P24010127-01, P23100161-01, P25070299-01, P25040073-01, P23120149-01, P23070081-01, P25070189-01, P25030104-01, P23110270-01, P23070099-01, P23050016-01
ARTG Number	95573
Unique Device Identifier (UDI)	08591794022177
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	The manufacturer has identified that the safety lock of the Y-connector (hereinafter referred to as the blue nut) may become loose (unscrewed) because it may not have been fixed by adhesive as required. If the blue nut is unscrewed, the gastric balloon of the Danis Stent delivery system cannot be inflated because the system is no longer fully airtight. This situation may result in the following: - The physician will not be able to place the delivery system correctly because of the inability to inflate the fixation (gastric) balloon. - The physician will have to stop the acute oesophageal variceal bleeding using a Danis Stent from another batch or other methods, which may prolong the procedure and bleeding. - The extension of the procedure may cause deterioration of the health condition of the patient. To date, no adverse events have been reported due to this problem.
Instructions for Customers/Users	Customers may continue to use the product while taking into account the additional instructions on the information sticker as outlined in the Customer Letter. Endotherapeutics is proposing that the information stickers be applied to the affected stock by an Endotherapeutics representative in person. Where this is not practicable, information sticker will be supplied to customers who has affected stock so that they can apply it themselves. This action has been closed out on 17/08/2026
Action Commencement Date	15/05/2026
Responsible Entity	Endotherapeutics Pty Ltd
Contact Information	02 9869 2868 - Endotherapeutics