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FDA · FDA event 95121 · Posted Oct 3, 2024
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.
The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.
| Model | Description | Lot / serial range | Manufactured | Status |
|---|---|---|---|---|
| Z-0001-2025 | Z-0001-2025 | REF/UDI-DI(GTIN): MMT-1714/00643169782396, 00763000253059; MMT-1715/00643169873841, 00763000190446, 00643169752726, 643169873834, 00763000317591, 00763000316655, 763000367053, 763000316655, 76300031665503, 763000190439, 763000316631, 763000166519, 763000072520, 76300031665501, 763000256807, 763000090197, 643169656840, 763000316686, 00643169656840, 00763000090197, 00763000190439, 00763000316631; MMT-1755/643169752726, 643169873841, 763000190446, 763000101527, 763000317591, 00763000317591, 763000367091, 763000179632, 763000317621, 643169878648, 763000157043, 76300031759103, 00643169752726, 76300031759101, 76300031762103, 76300031762101, 00763000101527, 00763000190446; MMT-1801/00763000531157; MMT-1805/00763000561680; MMT-1850/00763000552541; MMT-1851/00763000854737, 00763000541323. All serial numbers. | Not provided in the normalized record | Ongoing |
| Z-0003-2025 | Z-0003-2025 | 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. | Not provided in the normalized record | Ongoing |
| Z-0002-2025 | Z-0002-2025 | 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, 0064316952208… See the official FDA source for the complete identifier list. | Not provided in the normalized record | Ongoing |
Jul 31, 2024
Recall initiated
Date recorded by the FDA.
Oct 3, 2024
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.