| TGA Action ID |
RC-2026-RN-00092-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
YpsoPump Orbit Micro and YpsoPump Orbit Micro 2.0 Infusion Sets
Product codes (Orbit): MYOYP-1851, MYOYP-2451, MYOYP-2481, MYOYP-3151, MYOYP-3181, OYP-1005, and OYP-1008
Product codes (Orbit 2.0): MYOYP2-1851, MYOYP2-2451 |
| ARTG Number |
281787 |
| Action Type |
Product Correction |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
In 2024, a trend analysis indicated an increase in customer complaints concerning loose or broken needles at the YpsoPump Orbit Micro head component. An update to the Instructions for Use (IFU) is being implemented while an additional label (addendum) has been applied to all product cartons which includes supplementary instructions and a heatmap to indicate the recommended insertion points.
This action has been undertaken prior to notification to the TGA. |
| Instructions for Customers/Users |
- Read the Customer Letter, complete the Customer Response Form and return it to medical-affairs@mylife-diabetescare.com.au.
- Customers should review the addendum to IFU sticker label attached to Orbit Micro packaging.
UPDATE 10/09/26:
The IFU have now been updated and are available on the mylife DiabetesCare website.
The revised IFU will be included with the new, rebranded versions of the infusion sets, which have begun entering the Australian market. During the transition period, these updated infusion sets will coexist with the current versions, which will continue to include the sticker overlay. This transition period is expected to be completed by February 2027. |
| Action Commencement Date |
2/03/2026 |
| Responsible Entity |
|
| Contact Information |
1800 447 042 - Ypsomed |