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TGA Action ID	RC-2026-RN-00364-1
Type of Product	Medical Device
Product Name/Description	LivaNova Perfusion Tubing System (PTS) Product Codes: 076111015, 076189009, 076137013, 066648000, 066627001, 076418010, 076880003, 076876003, 077024002 Batch Numbers: PR1600052283, PR1600052650, PR1600052758, PR1600052363, PR1600052481, PR1600052540, PR1600052404, PR1600052500, PR1600052546, PR1600052408, PR1600052485, PR1600052417, PR1600052651, PR1600052568
ARTG Number	161865
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	LivaNova received two complaints relating to reverse-flow (backflow) performance of the 3/16" one-way high-flow check valve in a total of six (6) sold units. The problem was detected during circuit set-up/priming, and the defective condition was identifiable prior to patient use; no adverse effects were reported.? The one-way, high-flow check valve is intended as a safe measure against backflow and, more specifically, to prevent the potential ingress of air into the patient circuit in the event that an unexpected reverse flow occurs. Under certain conditions and in case of unintended line handling, an unexpected backflow may occur. To date, no adverse events have been reported due to this problem.
Instructions for Customers/Users	Customers are to: - Identify and quarantine affected devices immediately to prevent further use. - Contact a local Sales Representative to?arrange for the return of the affected product, and to order replacements. - Complete the Customer Response form and return it to Australia.QA@livanova.com This action has been closed out on 17/06/2026
Action Commencement Date	19/05/2026
Responsible Entity	LivaNova Australia Pty Ltd
Contact Information	1800 033 059 - LivaNova Australia