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TGA Action ID	RC-2025-RN-00525-1
Type of Product	Medical Device
Product Name/Description	ACURATE neo2 Aortic Valve Systems All lot numbers ACURATE neo2 Valve Material number: SYM-SV23-004, SYM-SV25-004, SYM-SV27-004 GTIN number: 07640168110130, 07640168110147, 07640168110154 ACURATE neo2 Transfemoral Delivery System Material number:SYM-DS-005, SYM-DS-010 GTIN number: 07640168110123, 00191506019402 ACURATE neo2 Loading Kit Material number: SYM-AC-010 GTIN number: 00191506019419
ARTG Number	401990
Action Type	Recall
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Boston Scientific is discontinuing global commercialisation of the ACURATE neo2 Aortic Valve System and is implementing a removal of any unused inventory of these devices.
Instructions for Customers/Users	Physicians should stop all implants of the ACURATE product platform. Further distribution or use of any remaining affected product should cease immediately. Customers should segregate all ACURATE neo2 product immediately and return it to Boston Scientific in accordance with the instructions in the customer letter. Boston Scientific recommends that patients who have been treated with an ACURATE neo2 valve should continue to follow standard of care and any additional patient management should be at the discretion of their physician on an individualised basis. This action has been closed out on 26/03/2026
Action Commencement Date	3/06/2025
Responsible Entity	Boston Scientific Pty Ltd
Contact Information	ANZ_Incident_Report@bsci.com