| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00506-1 |
| Product Name/Description |
Medtronic MiniMed Sure-T infusion sets
Model Numbers: MMT-860, MMT-862, MMT-863, MMT-864, MMT-865, MMT-866, MMT-870, MMT-873, MMT-874, MMT-875, MMT-876, MMT-883, MMT-884, MMT-885, MMT-886
ARTG # 119216 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/06/2015 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic identified that certain MiniMed Sure-T infusion sets had a slight increase of reported cases where the steel needle broke during use. In a small number of these reported cases, the needle break led to hospitalisation for the management of glucose levels and/or treatment for removal of the needle. Since then, an improvement in the needle manufacturing was implemented, which has reduced the number of reported cases of needle breaks. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
In the event consumers wish to carry on with using the old needle they are reminded to follow the current IFU along with specific additional instructions in the customer letter; OR if they prefer users (including members of the public) can phone Medtronic for replacement with unaffected stock. For more details, please see https://www.tga.gov.au/alert/medtronic-minimed-sure-t-infusion-sets. This action has been closed-out on 12/08/2016. |
| Contact Information |
1800 777 808 - Medtronic Australasia |