| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00968-1 |
| Product Name/Description |
MiniMed 640G insulin pump
Model Number: MMT-1751
Serial Numbers: NG1019509H, NG1019517H, NG1022331H
ARTG Number: 95763 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
30/09/2015 |
| Responsible Entity |
|
| Reason/Issue |
Medtronic has become aware of an issue potentially affecting specific MiniMed 640G insulin pumps. The pump drive motors may experience a malfunction, which would result in a pump error message alarm notifying users that insulin is no longer being delivered. Medtronic has identified the cause of the issue and it has been corrected in the current manufacturing of the MiniMed 640G.
To date, there have been no reported failures from customers as a result of this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Medtronic will directly send a replacement pump by courier to the three affected patients and then organise a suitable return courier for the pickup of these affected pumps. This action has been closed-out on 19/08/2016, |
| Contact Information |
1800 777 808 - Medtronic Customer Support Team |