| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2023-RN-00734-1 |
| Product Name/Description |
The Gallant, Entrant, and Neutrino NxT HV devices
Model numbers: CDVRA500Q, CDDRA500Q, CDHFA500Q, CDVRA600Q, CDDRA600Q, CDHFA600Q, CDVRA300Q, CDDRA300Q, and CDHFA300Q
ARTGs: 336475, 341252, 336476, 341253, 341254, 336479, 336477, 336478, 336480 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
17/08/2023 |
| Responsible Entity |
|
| Reason/Issue |
Abbott is informing customers of a rare potential for a Bluetooth (BLE) circuit component issue on a subset of Gallant, Neutrino, and Entrant Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) manufactured prior to April 2022.
This issue has been associated with a risk of loss of Bluetooth communication (and therefore a loss of remote monitoring), higher than normal current consumption, and reduced device longevity.
If a device experiences this issue, primary device functions, including pacing, sensing, shock delivery, and inductive telemetry, remain available during the period of remaining battery life. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Abbott advises customers:
· Prophylactic device replacement is NOT recommended as the new firmware version pr00.10.87.04 eliminates the potential for loss of therapy between follow-ups due to unrecognized decreased device longevity
· Determine the firmware version of devices followed at your clinic by reviewing the instructions in the customer letter
· For patients with firmware version pr00.10.87.00 or with firmware version undetermined, upgrade devices to device firmware version pr00.10.87.04 by interrogating patients in-clinic with Merlin PCS 3650 programmer Model 3330 software version 25.4.1 rev 1 or higher or any Merlin 2 PCS MER3700 programmer
· Prioritise in-clinic firmware upgrade for the specific devices from the 1,500 device sub-group listed in the customer letter
· For remaining patients, follow-up in-clinic to complete the firmware upgrade
· If a device experiences a loss of Bluetooth communication, contact Abbott Technical Support for troubleshooting.
This action has been closed out on 20/11/2023. |
| Contact Information |
02 8879 2877 - John Kilbridge |