FDA Device recall Z-0003-2025
MiniMed Insulin Pump Device
- FDA Device
- Class I
- ongoing
- Published 2024-10-09
On 2024-10-09 the FDA classified a Class I recall of MiniMed Insulin Pump Device by Medtronic Minimed, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0003-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-07-31 |
| Published | 2024-10-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medtronic Minimed |
| Distribution | 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, VT, WA, WI, WV, WY |
Product
MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762; MiniMed 770G, REF: MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892; MiniMed 780G, REF: MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896
Reason
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.
Identifiers
| code_info | REF/UDI-DI(GTIN): MMT-1780/00763000190453, 00643169946057, 00763000365882, 00763000096984, 00763000283445, 76300028351…REF/UDI-DI(GTIN): MMT-1780/00763000190453, 00643169946057, 00763000365882, 00763000096984, 00763000283445, 763000283513, 763000283506, 763000365882, 763000283520, 76300028351303, 763000393786, 763000166526, 76300028351301, 643169939202, 763000190460, 763000090203, 763000256821, 643169939219, 763000072537, 763000365912, 00763000090203, 00763000190460, 00763000283520, 00763000393786; MMT-1781/00763000187415, 00763000283568, 00763000283544, 00763000404536, 00763000283551, 00763000283537, 00763000365899, 00763000371937, 00763000225575, 00763000225582, 00763000235765, 00763000187378, 00763000140601, 763000240707, 763000187378, 763000140601, 763000283544; MMT-1782/00763000187422, 00763000235772, 00763000283599, 00763000264727, 00763000404543, 00763000283582, 00763000371944, 00763000365905, 00763000283575, 00643169957640, 00763000157463, 00763000225612, 763000225629, 763000225612, 763000264727; MMT-1741/00763000408916, 00763000408930; MMT-1742/00763000408947, 00763000250232, 007630004089 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0003-2025%22
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