| TGA Action ID |
RC-2025-RN-01032-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
basixCOMPAK Inflation Device
Catalog Code: IN4130/K |
| ARTG Number |
322582 |
| Action Type |
Product Alert |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
In rare instances, the handle may detach from the syringe during use due to an insufficient amount of adhesive on the handle, a condition that is not detectable prior to use. Handle detachment during use will result in residual contrast in the balloon, and procedural delay while another syringe is used to aspirate the residual contrast.
There has been an incident where it was reported that the balloon remained inflated after the handle detached, which occurred concurrently with a patient experiencing an adverse event. Simulated use testing has not replicated this failure, specifically the balloon remaining inflated after handle detachment.
The incidence rate for this failure is low at 0.0009%. |
| Instructions for Customers/Users |
No product return to Merit is required.
Customers are to follow the steps below to help mitigate the risk of detachment.
a. Holding the cap and barrel together during use may effectively prevent detachment.
b. Visual indicators such as pressure drops on the gauge can alert users to potential failures. Refer to the product Instructions for Use.
c. Simulated use testing showed that handle separation results in flow restoration.
d. Should the handle detach during use and the balloon not completely deflate, pull the handle out of the inflation syringe, disconnect the inflation syringe from the catheter, and use an alternate syringe to generate vacuum and aspirate residual contrast.
This action has been finalised on 4/11/2026. |
| Action Commencement Date |
11/12/2025 |
| Responsible Entity |
|
| Contact Information |
1300 696 374 - Merit Medical |