MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MMT-1780, MMT-1781, MMT-1782, MMT-1740, MM
Summary
The FDA issued a Class I for MiniMed Insulin Pump Device. MiniMed 670G, REF: MMT-1580, MMT-1581, MMT-1582, MM by Medtronic MiniMed, Inc.. Reason: Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause reduce.
Details
Source
Device Recall
External ID
Z-0003-2025
Action Date
2024-10-09
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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, 00763000408954; MMT-1760/763000278427, 763000283445, 643169946057, 763000190453, 763000096984, 643169946040, 00643169946057, 00763000190453, 00763000283445, 763000367084, 763000179649, 763000395858, 00763000096984; MMT-1761/763000187392, 00763000165451, 00763000165420, 00763000165468, 00763000165444, 00763000165437, 00763000257309, 00763000165413, 00763000289065, 00763000289089, 00763000289041, 00763000367657, 00763000289195, 00763000289096, 00763000289072, 00763000289058, 00763000324797, 00763000374518, 00763000374532, 00763000374525, 00763000374556, 00763000399849, 00763000399856, 00763000374587, 763000367657; MMT-1762/763000264710, 00763000264710, 00763000165475, 00763000165482, 00763000165499, 00763000165505, 00763000165512, 00763000165529, 00763000165536, 00763000165543, 00763000165550, 00763000203313, 00763000216481, 00763000252076, 00763000283476, 00763000289102, 00763000289119, 00763000289126, 00763000289133, 00763000289140, 00763000289164, 00763000289171, 00763000289188, 00763000324780, 00763000374594, 00763000374600, 00763000374624, 00763000399986; MMT-1880/00763000414344, 00763000545604, 00763000439859, 763000578640, 763000586195, 76300058619502, 763000439866, 763000413750, 76300057864002, 763000414344, 763000545604, 763000640095, 763000439859, 76300058619501, 00763000413750, 00763000586188; MMT-1881/00763000416546, 00763000439903, 00763000629892, 763000416546; MMT-1882/00763000416553, 00763000439910, 00763000545505, 00763000629908; MMT-1890/763000545604, 763000414344, 763000439859, 763000640095, 00763000414344, 00763000439859, 00763000545604, 76300054560402, 00763000640095, 76300064009502; MMT-1891/00763000642242, 00763000456634, 00763000642235, 00763000418151, 00763000482596; MMT-1892/00763000416553, 00763000439910, 00763000545505, 00763000629908; MMT-1884/00763000414344, 76300081937801, 76300081938501, 763000819378, 763000819385, 00763000586195, A7630007585401, 00763000758547, 00763000439866, 00763000578640, 00763000439859, 00763000545604, 00763000640095, 00763000819392, 763000545604, 00763000758530, 00763000504762; MMT-1885/00763000384258, 00763000521523, 00763000442187, 00763000521509, 00763000578671, 00763000639228, 00763000421939, 00763000597900, 00763000854942, 00763000854829, A7630006392201, 763000384272, 763000521523, 763000854829; MMT-1886/00763000384265, 00763000441449, 00763000521530, 00763000521516, 00763000578688, 00763000442194, 00763000639235, 763000384289, 763000521530, 76300044240801, 763000688165, 76300063923501; MMT-1894/76300086566501, 76300075854701, 763000758547, 763000819392, 763000865665, 00763000758547, 00763000819392; MMT-1895/00763000411411, 00763000734435, 00763000411473, 00763000411466, 00763000541569, 00763000411480, 00763000420703, 00763000411428, 00763000596217, 00763000411404, 00763000533861, 00763000411381, 00763000411503, 00763000596187, 00763000411398, 00763000596194, 00763000411374, 00763000411442, 00763000411435, 00763000411497, 00763000411459, 00763000596224, 00763000411633, 00763000596231, 00763000639266, 00763000384272, 00763000521547, 00763000732585, 763000734435; MMT-1896/763000521554,00763000411510, 00763000411565, 00763000411640, 00763000411541, 00763000411589, 00763000734442, 00763000411527, 00763000411626, 00763000411602, 00763000411558, 00763000523305, 00763000411572, 00763000411596, 00763000914127, 00763000411619, 00763000411534, 00763000734459, 00763000544317, 00763000913250, 00763000533878, 00763000521554, 00763000384289, 00763000639273, 763000734442; All serial numbers.
Quantity Affected: 526,558
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.
Distribution
US: CT, MI, PA, WA, IA, NY, ND, AZ, TX, OH, NC, AL, MN, IN, NJ, KY, UT, CA, FL, VA, MS, NM, NV, TN, GA, MA, NH, OK, VT, IL, ME, SC, LA, WY, RI, SD, KS, WI, MD, CO, DE, AR, AK, ID, MO, NE, WV, MT, OR, DC, HI, VI, PR. OUS: Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-31
Company
Northridge, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 218 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Medtronic MiniMed, Inc. has 43 FDA actions in our database, including 37 recalls and 6 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medtronic MiniMed, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medtronic MiniMed, Inc. have FDA actions?
Medtronic MiniMed, Inc. has 43 FDA actions in our database, including 37 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0003-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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