Class II — Medtronic MiniMed
| Recalling firm | Medtronic |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| Product | MiniMed 630G: MMT-1715, MMT-1754, MMT-1755; MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782; MiniMed 770G: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 620G (OUS Only): MMT-1750; MiniMed 640G (OUS Only): MMT-1711, MMT-1712, MMT-1751, MMT-1752; MiniMed 720G (OUS Only): MMT-1809, MMT-1810, MMT-1859, MMT-1860; MiniMed 740G (OUS Only): MMT-1811, MMT-1812, MMT-1861, MMT-1862; MiniMed 780G (OUS Only): MMT-1884, MMT-1885, MMT-1886, MMT-1895, MMT-1896 The MiniMed" 630G System with SmartGuard is intended for continu… |
| Quantity | 175,801 |
| Distribution | US: OH, UT, IL, NY, FL, LA, NE, NV, CA, VA, TX, DE, KS, MS, MI, AL, OK, AZ, SC, IN, AR, PA, WV, MA, RI, NJ, CO, TN, KY, GA, WI, MN, NM, MD, IA, NC, WY, MO, WA, OR, CT, ND, ME, VT, ID, SD, AK, MT, NH, DC, HI, PR, VI OUS: Australia, Japan, Korea, New Zealand, Taiwan, Viet Nam |
| Initiated | 2022-01-27 |
| Classified | 2022-03-31 |
| Recall number | Z-0855-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Medtronic MiniMed (Z-0855-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89653/
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