Recall MonitorHealth Products
Paradigm and MiniMed 600 and 700 series pumps
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General hospital and personal use
Product: Paradigm and MiniMed 600 and 700 series pumps
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: General public
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Minimed 630g | All lots. | MMT-1714 |
| Paradigm 754 Insulin Pump | All lots. | MMT-754 |
| Minimed 780g Kit | All lots. | MMT-1895 |
| Minimed 670g | All lots. | MMT-1782 |
| Paradigm 554 Insulin Pump | All lots. | MMT-554 |
| Minimed 770g | All lots. | MMT-1891 |
| Minimed 770g | All lots. | MMT-1881 |
| Minimed 670g Kit | All lots. | MMT-1762 |
| Minimed 780g Pump | All lots. | MMT-1885 |
Issue
As part of the testing for the Alternate Controller Enabled (ACE) device submission, the R&D team tested the Minimed 780g Insulin Pump at elevated and lowered height conditions relative to the infusion site per the engineering test report. The results of the testing showed that there is an unintended over or under delivery of insulin that occurs when the 780g pump is either elevated or lowered relative to the infusion site.