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Type of Product	Medical Device
TGA Recall Reference	RC-2023-RN-00957-1
Product Name/Description	EZDilate Fixed Wire Balloon Multiple product codes ARTG 279847 (Olympus Australia Pty Ltd - Catheter gastrointestinal balloon)
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	6/11/2023
Responsible Entity	Olympus Australia Pty Ltd
Reason/Issue	Some batches of the EZDilate Wire Guided Balloon have inflating, deflating and/or retrieving issues, as well as bursting and leaking associated with them. Possible risks associated with this issue include the potential for foreign body in patients and prolonged procedure time. Potential serious harms include haemorrhage, haematoma, tissue injury, aspiration, and additional surgery. There have been several complaints related to this issue worldwide and a solution to this defect has been implemented by the manufacturer, therefore new LOT numbers are not impacted.
Recall Action	Recall
Recall Action Instructions	Customers are to inspect their inventory to identify any models and batch numbers impacted. They are to quarantine and cease use of affected devices, as well as organise returning of stock to Olympus. The model and LOT number can be found on the box or pouch as illustrated in the customer letter. Any models and LOT numbers that are not impacted can remain in inventory and may be used.
Contact Information	1300 132 992 - Olympus Australia Pty Ltd