| TGA Action ID |
RC-2026-RN-00745-1 |
| Type of Product |
Medical Device |
| Product Name/Description |
Ventilation (tympanostomy) Tube 5PK Button 1.27 FLPL
Catalogue Number: 1013301
Lot Number: 0231048280
GTIN: 20763000281636 |
| ARTG Number |
126695 |
| Action Type |
Recall |
| Action Level |
Hospital |
| Hazard Classification |
Class II |
| Reason for the Action |
Medtronic is recalling a certain lot of Ventilation (tympanostomy) Tubes that were distributed without undergoing the required sterilisation process.
After implantation this could cause infection and subsequent inflammation potentially leading to temporary hearing impairment, otorrhea (fluid discharge) and the need for antibiotics.
As of September 10, 2026, Medtronic has received no complaints associated with the affected lot and no reports of patient harm related to these devices. |
| Instructions for Customers/Users |
Customers are to:
- Stop using and quarantine the affected product.
- Return unused affected stock following the instructions in the customer letter.
Medtronic advises that explant is not recommended for devices already implanted as the devices are fully functional and continue to provide their clinical benefit.
As a precautionary measure, patients implanted with devices from affected lot numbers should continue to be monitored in accordance with standard clinical practice. |
| Action Commencement Date |
25/09/2026 |
| Responsible Entity |
|
| Contact Information |
0455 381 881 - April Bingham, Medtronic |