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Type of Product	Medical Device
TGA Recall Reference	RC-2024-RN-00261-1
Product Name/Description	HeartWare Ventricular Assist Device (HVAD) System ARTG 181875 (Medtronic Australasia Pty Ltd - Heartware Ventricular Assist System - Implantable ventricular circulatory assist system)
Recall Action Level	Hospital
Recall Action Classification	Class I
Recall Action Commencement Date	2/04/2024
Responsible Entity	Medtronic Australasia Pty Ltd
Reason/Issue	Medtronic is informing via follow-up notice to prior communications (December 2020, May 2021, December 2021, October 2022, August 2023, and September 2023) about updates to patient management recommendations around power source management and new information included in Autologs and HVADlogs reports. Updated rates relating to failure or delay to restart events are similar to what have been previously communicated to customers. The inability to restart or the delay in restart problems could lead to different potential harms such as hypoperfusion, cardiac arrest, death, pump exchange/reoperation, thrombus, worsening heart failure or hospitalisation.
Recall Action	Product Defect Correction
Recall Action Instructions	Customers are required to read and understand the updated patient power source management recommendations outlined in the customer letter. Medtronic recommends taking advantage of their HVADlogs and Autologs service by uploading controller logfiles with each patient visit. New information regarding motor start events is now available for customers. Medtronic requests clinicians to submit the logfiles to HVADlogs for further review by the Medtronic Technical Services Team. A Medtronic Representative will then reach out to discuss the motor start events and how those events may be useful in the management of patients.
Contact Information	0478 486 782 - Arthur Preovolos