MiniMed Insulin Pump Device. MiniMed recall
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…
Why was MiniMed Insulin Pump Device. MiniMed recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- 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…
- Recalling firm
- Medtronic MiniMed, Inc.
- Quantity
- 526,558
- 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 date
- October 9, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)