Reported Apr 6, 2022 · Ongoing
MiniMed 630G
Medtronic MiniMed
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic MiniMed · 18000 Devonshire St · Northridge, CA · 91325-1219
Is this the product you have?
MiniMed 630G
8 of 8 products
| # | Product as published |
|---|---|
| 1 | MMT-1715, MMT-1754, MMT-1755 |
| 2 | MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782 |
| 3 | MiniMed 770G: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892 |
| 4 | MiniMed 620G (OUS Only): MMT-1750 |
| 5 | MiniMed 640G (OUS Only): MMT-1711, MMT-1712, MMT-1751, MMT-1752 |
| 6 | MiniMed 720G (OUS Only): MMT-1809, MMT-1810, MMT-1859, MMT-1860 |
| 7 | MiniMed 740G (OUS Only): MMT-1811, MMT-1812, MMT-1861, MMT-1862 |
| 8 | MiniMed 780G (OUS Only): MMT-1884, MMT-1885, MMT-1886, MMT-1895, MMT-1896 The MiniMed" 630G System with SmartGuard is intended for continuous delivery of basal insulin (at user selected rates) and administration of insulin boluses (in user selectable amounts) for the management of Type 1 diabetes mellitus in persons sixteen years of age and older. |
- Lot codes and dates
- Insulin pumps distributed in the last 6 months. All devices (US) serial numbers ranging from NG2056884H TO NG2891033H and (OUS) serial numbers ranging from NG1921788H TO NG2883091
- Amount recalled
- 175,801
Where it was sold
Why it was recalled
New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.), which must be set up and saved on pumps prior to use. Patients who do not realize this will receive no basal insulin, which can lead to insulin under-delivery. Insulin under-delivery can cause severe hyperglycemia, which may lead to diabetic ketoacidosis. Current device labeling does not clearly identify that these insulin pumps are capable of functioning with the default basal setting of 0.0 units/hr for all 24 hours and that no error message will appear if the default basal setting remains active. Furthermore, the labeling for the affected devices does not highlight that saving the basal settings requires multiple steps and failure to complete all steps will not save the new basal settings, nor that the steps required to set and save a basal profile and other parameters which are used as part of the bolus calculator function are different.
This product could cause temporary or reversible health problems — stop using it.
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