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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00325-1
Product Name/Description	Esoflip Dilation Catheter 30mm Model Number: ES-330 GTIN Number: A8845218094503 Lot Number: 23D0777JZ ARTG 317482
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	24/04/2024
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Specific lot numbers of Esoflip dilation catheter 30mm – Model # ES-330 may have non-conformances in saline conductivity that could negatively impact the performance of the product as indicated. If such devices are used, inaccurate oesophageal diameter measurements may lead to the following harms: delay to treatment, pain, bleeding, oesophageal laceration, oesophageal perforation, or respiratory distress. From 01 April 2022 through 31 March 2024, there were 167 complaints related to catheters with low saline conductivity.
Recall Action	Recall
Recall Action Instructions	Customers are to: • Immediately identify and quarantine all unused Esoflip dilation catheter 30mm – Model # ES-330 from the affected lot number to prevent further use. Return affected product to Medtronic. • If purchased from a distributor, contact them directly to arrange for the return of the product. There are no additional actions required for patients where an Esoflip dilation catheter 30mm – Model # ES-330 was used during a procedure. These patients should continue to be monitored in accordance with each medical facility’s standard care protocols. This action has been closed out on 27/6/2024.
Contact Information	0421 275 044 - Simon Turner