Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2018-RN-00669-1
Product Name/Description Fortify, Fortify Assura, Quadra Assura, Quadra Assura MP, Unify, Unify Assura, Unify Quadra, Promote Quadra and Ellipse ICD & CRT-D Devices

Battery performance update applies to devices manufactured prior to 23 May 2015

Multiple Models

Multiple ARTG Numbers
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 31/05/2018
Responsible Entity Abbott Medical Australia Pty Ltd
Reason/Issue Further to the Safety Alert communication of April 24th 2018 (RC-2018-RN-00337-1), Abbott is now advising of the firmware update availability.

As part of a planned series of system updates that began in 2017 with the release of Merlin@home v8.2.2 software, A firmware update has been developed with the intention to further strengthen the security and improve the performance of high voltage implantable cardiac devices (ICDs and CRT-Ds). The firmware upgrade is recommended for all eligible patients and includes the following updates:

1. a battery performance alert update to provide further detection capability for premature battery depletion in certain high voltage devices (i.e. Battery Advisory Devices), and
2. a cybersecurity update to provide an additional layer of protection against unauthorised device access.
Recall Action Hazard Alert
Recall Action Instructions The software upgrade indicated in the previous communication RC-2018-RN-00337-1 will be available in the first week of June 2018.

Abbott is contacting doctors (physicians) to provide details regarding risk and patient management recommendations. Surgeons should consider the information in the letter and their patient's circumstances in deciding whether to update the firmware in implanted devices.

This action has been reviewed and is considered complete in accordance with the requirements of the URPTG.
Contact Information 1800 839 259 - Abbott Customer Service