Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00632-1
Product Name/Description Medtronic MiniMed 640G Insulin Pumps

Model Numbers – MMT - 1511, 1512, 1711 & 1712

ARTG Number: 95763
Recall Action Level Consumer
Recall Action Classification Class I
Recall Action Commencement Date 20/07/2015
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue Issue 1 – Users could inadvertently extend the Blood Glucose Timestamp for a given Blood Glucose value by 12 minutes leading to a potentially incorrect bolus dose calculation. Medtronic is currently not aware of any malfunctions, complaints, adverse effects, disease, illness, injuries or confirmed deaths related to this issue;


Issue 2 – The ‘Max Bolus Exceeded’ & ‘High/Low’ Blood Glucose Notification warning pop-ups for the Bolus Wizard software are not timing out which may lead to confusion. There are no reported harms due to the combination of potential user error and pop up screens not timing out.
Recall Action Recall for Product Correction
Recall Action Instructions Medtronic has updated the user guide to rectify this issue. For more details, please see This action has been closed-out on 15/08/2016.
Contact Information 1800 777 808 - Medtronic HelpLine