MiniMed 630G Insulin Pump — Class I medical device recall Z-0001-2025
Ongoing recall by Medtronic MiniMed, Inc., reported 2024-10-09, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal elect
| Recall number | Z-0001-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic MiniMed, Inc., Northridge, CA, United States |
| Recall initiated | 2024-07-31 |
| Classified | 2024-10-03 |
| Reported by FDA | 2024-10-09 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY |
| Quantity | 24,595 |
| UPC / GTIN / UDI-DI | 00643169656840, 00643169752726, 00643169782396, 00643169873834, 00643169873841, 00643169878648, 00763000072520, 00763000090197, 00763000101527, 00763000157043, 00763000166519, 00763000179632, 00763000190439, 00763000190446, 00763000253059, 00763000256807, 00763000316631, 00763000316655, 00763000316686, 00763000317591, 00763000317621, 00763000367053, 00763000367091, 00763000531157, 00763000541323 and 3 more |
| Model numbers | MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755, MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851 |
Product
MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF: MMT-1800, MMT-1801, MMT-1805, MMT-1850, MMT-1851
Reason for recall
Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduced pump battery life. Since the defect reduces the battery life overall, it shortens the time between low battery alarms and increases the frequency with which the user must insert a new battery. Further, the defect may also deliver the low battery alarm when there is significantly less time before the battery completely runs out, from the expected up to 10-hour buffer the low alert is supposed to signal, leading to device powering down and stopping insulin delivery unexpectedly. Per the firm, a subset of pumps with the defect showed the low alert alarm was delivered ~2.5 hours before the device shut off, however, patient reports indicate the time could be even shorter. Replacing the battery will not resolve this issue and the short battery life and the truncated low battery alert lead time will continue to occur. Early battery depletion could result in power loss and insulin delivery could be interrupted, resulting in under delivery of insulin potentially leading to hyperglycemia and/or DKA.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0001-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.