| TGA Action ID |
RC-2025-RN-00686-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Grip Cable on da Vinci X and Xi Reusable Instruments with Jaws
Multiple product names, product codes and UDI numbers |
| ARTG Number |
146826, 317670, 318465, 319143 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
There are two grip cables in these instruments (used with da Vinci X and da Vinci Xi systems) which control the opening and closing of the jaws of the instrument. A grip cable can fail partially (i.e., frayed) or completely (i.e., broken).
A broken grip cable can lead to loss of grip functionality, exposure to frayed cables, or the potential for tungsten cable particulate to fall into the patient.
This recall is a follow-up to the Urgent Product Defect Alert (RC-2025-RN-00020-1) dated 21st January 2025. Updated versions of the X and Xi instruments with jaws that have improved cables, reducing the potential for grip cable breakage, are now available. |
| Instructions for Customers/Users |
Customers are to inspect their stock and identify the product code(s), the quantity and batch number(s) and version number(s) of the affected devices in their inventory, and detail these on the Response Form.
Device Technologies will be in contact with customers to arrange the collection of affected stock and provide remuneration.
UPDATE 25/08/25: Due to the high volume of returns, there may be some supply shortages of the Monopolar Curved Scissors (Hot Shears) with Product Number 470179. Replacements are currently available for all other products to be recalled, and return of these devices can occur as soon as replacement stock is received at the customer’s facility.
Until replacements are provided, devices may continue to be used under the following conditions:
• Inspect instruments prior to use for any signs of frayed or broken grip cables.
• Discontinue use immediately if any cable damage is observed before, during, or after a procedure.
• Report any adverse events or quality issues via the standard complaint process.
• Discontinue use once replacement products have been received.
This action has been closed out on 29/10/2026 |
| Action Commencement Date |
18/08/2025 |
| Responsible Entity |
|
| Contact Information |
1300 338 423 - Device Technologies Australia |