| TGA Action ID |
RC-2026-RN-00801-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Grip Cable on da Vinci X/Xi & dV5 Reusable Instruments with Jaws
Affected Product Numbers: 470033, 470036, 470048, 470093, 470181, 470190, 470347, 471048, 471190, 470171, 470344, 471171, 471344, 471405, 470401
470230, 470327, 470194, 470309, 471296, 471309, 470001, 470007, 470246, 470249
Multiple Versions & Product Names |
| ARTG Number |
146826, 317670, 319142, 319143, 319144, 319418 |
| Unique Device Identifier (UDI) |
Various, see Appendix A in Customer Letter. |
| 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 Recall (RC-2025-RN-00686-1) dated 19 August 2025. Additional 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 return of affected devices. Device Technologies will provide credit on lives remaining on returned affected stock.
UPDATE 16/10/2026:
Replacements are currently available for the affected products and return of these devices can occur as soon as replacement stock is received at your 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. |
| Action Commencement Date |
13/10/2026 |
| Responsible Entity |
|
| Contact Information |
1300 338 423 - Device Technologies Australia |