| TGA Action ID |
RC-2026-RN-00385-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
FlexAbility Ablation Catheter, FlexAbility Ablation Catheter (Sensor Enabled) and TactiFlex Ablation Catheter (Sensor Enabled) family of products
All models |
| ARTG Number |
327822, 327823, 327824, 327825, 380981, 380982 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Abbott is informing customers of clarified indications for the FlexAbility Ablation Catheter, FlexAbility Ablation Catheter Sensor Enabled and TactiFlex Ablation Catheter Sensor Enabled family of products. Indications specific to epicardial ablations for patients with ventricular tachycardia have been clarified. |
| Instructions for Customers/Users |
Health professionals should read the customer letter and maintain awareness of the updated indications.
This action has been closed out on 09/10/2026 |
| Action Commencement Date |
3/06/2026 |
| Responsible Entity |
|
| Contact Information |
1800 839 259 - Abbott Medical |