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TGA Action ID	RC-2025-RN-00813-1
Type of Product	Medical Device
Product Name/Description	Automated Impella Controller (AIC) Impella Controller, Packaged, AU Product Code: 0042-0000-AU Serial Numbers: IC5521, IC5677, IC6531, IC7288, IC7289 AIC, Optical, Impella Connect, Packaged, AU Product Code:0042-0040-AU Serial Numbers: IC10162, IC10163, IC10387, IC10388, IC10747, IC10748, IC11472, IC11490, IC11544, IC11546, IC11566
ARTG Number	288729
Action Type	Product Correction
Action Level	Hospital
Hazard Classification	Class II
Reason for the Action	Abiomed identified a rate of 0.61% AIC purge pressure problems due to purge retainer failures. When this problem arose, it was determined that force applied during purge disc insertion/removal was a factor contributing to the purge retainer failures. Abiomed identified a design change to correct the AIC purge retainer fixture that will be implemented through device servicing. This design change involves the addition of a third mounting screw for the purge retainer, improving fixation. Currently this rate is 0.19% (105 complaints out of 55,471 cases from August 2024 to June 2025). The review of complaints determined that there have been no deaths but 5 serious injuries directly related to this failure.
Instructions for Customers/Users	Abiomed will contact customers with affected AIC product to arrange and implement the necessary correction. Once contacted by Abiomed’s representative, customers should work with them to set an appointment for the change to be implemented. Hospital inventory can continue to be used to ensure continuity of care. This action has been finalised on 23/12/2025.
Action Commencement Date	26/09/2025
Responsible Entity	Abiomed Australia Pty Ltd
Contact Information	0424 960 142 – David Fletcher, Abiomed Australia