FDA Device Recall Z-0002-2025

Device

MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750; MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 640G Insulin Pump, REF: MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, MMT-1752; MiniMed 720G Insulin Pump, REF: MMT-1809, MMT-1810, MMT-1817, MMT-1818, MMT-1859, MMT-1860, MMT-1867, MMT-1868 MiniMed 740G Insulin Pump, REF: MMT-1811, MMT-1812, MMT-1861, MMT-1862

Lot / serial / GTIN: REF/UDI-DI(GTIN): MMT-1710/00643169568419; MMT-1750/00763000253189, 00763000375461, 00643169721319, 00643169559745, 763000253189; MMT-1714/00763000253059, 00763000074845, 00643169782396, 763000253059, 643169782396; MMT-1715/ 00763000316631, 763000190439, 763000316631; MMT-1754/00763000253066, 00643169976344, 00763000315719, 00763000381912, 763000253066; MMT-1755/643169752726, 643169873841, 763000190446, 763000101527, 763000317591, 00763000317591, 763000367091, 763000179632, 763000317621, 643169878648, 763000157043, 76300031759103, 00643169752726, 76300031759101, 76300031762103, 76300031762101, 00763000101527, 00763000190446; MMT-1711/00643169662568, 00763000317119, 00763000317089, 00763000404550, 00763000367039, 00763000317102, 00643169662544, 00643169739468, 00643169554931, 00763000192136, 00763000068998, 00763000198596, 00643169662575, 00763000065195, 00763000258337, 00643169999763, 00643169739451, 00643169739475, 00643169739444, 00643169739482, 00763000192211, 00643169729353, 00643169554924, 00763000013066, 00643169554948, 00643169554917, 00643169966284, 00643169629813, 00643169662582, 00643169554955, 00643169966277, 00643169966260, 00643169966307, 00643169966291, 00643169662551, 643169890039, 763000367039, 763000317089, 763000192211, 763000317119, 643169739444, 643169554931, 643169739468; MMT-1712/00763000367046, 00763000317157, 00763000317195, 00763000404567, 00763000192143, 00763000317188, 00763000317140, 00763000065201, 00763000317164, 00643169739512, 00763000069001, 00763000258344, 00643169662636, 00643169999770, 00643169577664, 00763000155346, 00763000198602, 00763000192228, 00643169729360, 00643169739499, 00643169739505, 00643169577688, 00643169739536, 00643169662612, 00643169739529, 00643169629820, 00643169577701, 00643169662599, 00643169577695, 00643169966338, 00643169966352, 00643169966314, 00643169966321, 00643169577671, 00643169662629, 00643169662605, 00643169966345, 763000317195, 763000317140, 763000192228, 643169739512, 643169577688, 643169999770, 763000317157, 763000367046, 643169739505; MMT-1751/00763000194246, 00763000319489, 00763000319359, 00763000319410, 00763000319458, 00763000319519, 00643169521179, 00763000324698, 00763000319366, 00763000194338, 00763000319434, 00763000319533, 00763000324681, 00643169999787, 00763000319380, 00763000319427, 00763000319526, 00763000402686, 00763000319397, 00763000015534, 00763000319342, 00763000402693, 00763000192198, 00763000319373, 00763000319496, 00763000194291, 00643169672239, 00763000002855, 00763000402709, 00763000194352, 00763000015558, 00763000002787, 00763000253288, 00763000165185, 00763000165123, 00643169682849, 00763000015510, 00763000319441, 00643169672253, 00763000319403, 00763000165109, 00763000015480, 00643169683143, 00763000194314, 00643169672246, 00763000194475, 00763000165130, 00763000165154, 00763000083441, 00763000165093, 00763000165116, 00763000165147, 00763000074814, 00763000194345, 00763000194277, 00763000165222, 00763000194307, 00763000165215, 00763000002824, 00643169682245, 00643169682603, 00763000194239, 00763000194253, 00763000194321, 00763000194222, 00643169682269, 00763000002817, 00643169682061, 00763000194260, 00763000015572, 00763000002831, 00643169682337, 00763000015497, 00763000002763, 00643169682085, 00763000015589, 00643169585270, 00763000015503, 00763000015596, 00643169683129, 00643169672277, 00643169522046, 00763000015541, 00763000015565, 00643169682313, 00643169643680, 00643169643413, 00643169682535, 00643169682801, 00643169681996, 00643169521995, 00643169521445, 00643169585294, 00643169682054, 00643169682047, 00643169672260, 00763000002770, 00763000002848, 00763000002879, 00763000002886, 00763000002756, 00643169522060, 00643169682870, 00763000002794, 00763000015459, 00763000002800, 00643169521247, 00643169585256, 00763000002862, 00643169683075, 00643169682351, 00643169522022, 00643169629653, 00643169643710, 00643169682894, 00643169682641, 00643169682009, 00643169682108, 00643169681972, 00643169682627, 00643169683181, 00643169682580, 00643169683167, 00643169682566, 00643169682832, 00643169682023, 00643169682016, 00643169682252, 00643169682917, 00643169682375, 00643169681989, 00643169682078, 00643169683136, 00643169682276, 00643169682030, 00643169682511, 00643169682788, 00643169683051, 00643169682856, 00643169682795, 00643169644274, 00643169643444, 00643169682306, 00643169643482, 00643169683068, 00643169682818, 00643169521520, 00643169643758, 00643169629691, 00643169629677, 00643169643666, 00643169683082, 00643169683105, 00643169682290, 00643169521797, 00643169682825, 00643169682542, 00643169682559, 00643169683099, 00643169521209, 00643169682283, 00643169643956, 00643169643772, 00643169629660, 00643169682528, 00643169521728, 00643169629684, 00643169521544, 00643169644205, 00643169643529, 00643169643505, 00643169521155, 00643169644021, 00643169643468, 00643169644298, 00643169644335, 00643169643987, 00643169644007, 00643169644229, 00643169522084, 00643169521261, 00643169521810, 00643169643390, 00643169521421, 00643169644250, 00643169521568, 00643169643963, 00643169643932, 00643169644045, 00643169521438, 00643169521506, 00643169643734, 00643169521162, 00643169643703, 00643169644236, 00643169643741, 00643169521704, 00643169521476, 00643169644281, 00643169521988, 00643169644243, 00643169521285, 00643169521773, 00643169521971, 00643169522107, 00643169643949, 00643169643697, 00643169521834, 00643169643420, 00643169521223, 00643169643512, 00643169522008, 00643169585287, 00643169521216, 00643169521186, 00643169522015, 00643169521759, 00643169521193, 00643169522053, 00643169521742, 00643169521230, 00643169521780, 00643169521513, 00643169521766, 00643169521469, 00643169585263, 00643169521254, 00643169522077, 00643169521537, 00643169521803, 00643169521711, 00643169643123, 00643169520967, 00643169643253, 00643169520882, 00643169520905, 00643169643208, 00643169643192, 00643169520950, 00643169643178, 00643169643130, 00643169643215, 00643169643154, 00643169643161, 00643169643147, 00643169520974, 00643169520912, 00643169520929, 00643169521018, 00643169520998, 00643169643185, 00643169520943, 00643169520936, 00643169520981, 00643169520899, 00643169643239, 00643169643222, 00643169668829, 00643169574410, 00643169574441, 00643169574434, 00643169574427, 00643169574458, 00643169521735, 00643169521452, 00763000316525; MMT-1752/00763000102593, 00763000318307, 00763000393809, 00643169682474, 00643169682382, 00763000194666, 00763000324704, 00763000194444, 00763000165277, 00763000194383, 00763000319571, 00763000165246, 00763000115968, 00643169521339, 00763000319540, 00763000319274, 00763000194468, 00763000319564, 00763000192204, 00763000318291, 00643169682412, 00763000194451, 00763000165307, 00643169682436, 00763000194390, 00643169643574, 00763000194376, 00643169643581, 00643169521346, 00763000165345, 00763000319618, 00763000319311, 00763000319267, 00763000194369, 00763000165284, 00763000319243, 00763000165338, 00763000319304, 00763000165260, 00763000074821, 00763000194413, 00763000319595, 00763000194406, 00643169682429, 00763000319328, 00763000194420, 00763000319298, 00763000165314, 00763000319557, 00763000319229, 00643169682498, 00763000319588, 00643169999800, 00763000194437, 00643169643628, 00643169521384, 00643169721289, 00643169521292, 00643169643642, 00643169682405, 00643169682443, 00643169521360, 00643169596443, 00643169682450, 00643169596405, 00643169643536, 00643169596382, 00643169521315, 00643169521407, 00643169643567, 00643169643598, 00643169643550, 00643169522305, 00643169521322, 00643169521353, 00643169643260, 00643169643352, 00643169643895, 00643169521612, 00643169521667, 00643169521896, 00643169644120, 00643169644113, 00643169644076, 00643169643314, 00643169643307, 00643169521025, 00643169643802, 00643169644397, 00643169522152, 00643169521117, 00643169644434, 00643169644342, 00643169643871, 00643169644380, 00643169522114, 00643169521049, 00643169521063, 00643169552388, 00643169521872, 00643169521087, 00643169521629, 00643169521575, 00643169522169, 00643169522176, 00643169522145, 00643169643321, 00643169521681, 00643169522138, 00643169521070, 00643169521889, 00643169521841, 00643169521865, 00643169521131, 00643169522206, 00643169521933, 00643169643840, 00643169521605, 00643169521957, 00643169643857, 00643169643864, 00643169644373, 00643169643291, 00643169644182, 00643169643826, 00643169643338, 00643169644168, 00643169644458, 00643169643918, 00643169643833, 00643169644106, 00643169643376, 00643169644410, 00643169644403, 00643169682115, 00643169682153, 00643169683013, 00643169682924, 00643169682962, 00643169682160, 00643169682658, 00643169682696, 00643169683198, 00643169683242, 00643169683280, 00643169683303, 00643169682221, 00643169682207, 00643169682146, 00643169682979, 00643169682184, 00643169682177, 00643169682764, 00643169682702, 00643169682740, 00643169682672, 00643169683235, 00643169683228, 00643169682139, 00643169682955, 00643169683211, 00643169683037, 00643169682948, 00643169683266, 00643169682993, 00643169682689, 00643169682719, 00643169682214, 00643169683259, 00643169682986, 00643169682191, 00763000002633, 00763000002749, 00643169966246, 00763000002671, 00763000002664, 00763000002725, 00643169966253, 00643169668874, 00763000002732, 00763000002695, 00763000002688, 00763000002657, 00643169999817, 00763000002701, 00763000002718, 00763000002640, 00763000015381, 00763000015367, 00763000015435, 00763000015336, 00763000015374, 00763000015398, 00763000015411, 00763000015428, 00763000015350, 00763000015343, 00763000015404, 00763000015442, 00763000069025, 00763000319281, 00763000347536, 00643169521902, 00643169521636, 00643169521056, 00643169522183, 00643169521094, 00643169522381, 00643169522268, 00643169522343, 00643169521100, 00643169521919, 00643169521599, 00643169521643, 00763000319236, 763000255633; MMT-1809/00763000484644, 00763000541330, 00763000769413; MMT-1810/00763000484651, 00763000541347, 00763000769420, 00763000496302; MMT-1859/00763000505196, 00763000505257, 00763000505219, 00763000505318, 00763000505226, 00763000505288, 00763000505271, 00763000505233, 00763000505295; MMT-1860/00763000505387, 00763000505332, 00763000505370, 00763000531171, 00763000505394, 00763000505400, 00763000854768, 00763000505356, 00763000505349, 00763000505325; MMT-1867/00763000638016; MMT-1811/00763000629984, 00763000769451; MMT-1812/00763000484637, 00763000629991, 00763000769468; MMT-1861/00763000504922, 00763000504977, 00763000559557, 00763000504915, 00763000505028, 00763000504960, 00763000504984, 00763000504892, 00763000504861, 00763000504991, 00763000504953, 00763000504908, 00763000504946, 00763000505042, 00763000505004, 00763000505059, 00763000851224, 00763000851217, 00763000504939, 00763000504878; MMT-1862/00763000505080, 00763000505127, 00763000505110, 00763000505158, 00763000505172, 00763000505073, 00763000505066, 00763000505134, 00763000505103, 00763000505189, 00763000505141, 00763000505097, 00763000505165. All serial numbers.

Quantity: 234,360

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.

Recall record

Recall number

Z-0002-2025

Classification

Class I

Status

Ongoing

Voluntary or mandated

Voluntary: Firm initiated

Firm notification

Letter

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

Recall initiated

2024-07-31

Classified by FDA Center

2024-10-03

FDA published

2024-10-09

Recalling firm

Medtronic MiniMed, Inc.

Firm location

Northridge, CA