{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "209613", "product_res_number": "Z-0002-2025", "event_date_initiated": "2024-07-31", "event_date_posted": "2024-10-03", "recall_status": "Open, Classified", "res_event_number": "95121", "product_code": "OYC", "product_description": "MiniMed 620G Insulin Pump, REF: MMT-1510, MMT-1710, MMT-1750;\nMiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755;\nMiniMed 640G Insulin Pump, REF: MMT-1511, MMT-1711, MMT-1512, MMT-1712, MMT-1751, MMT-1752;\nMiniMed 720G Insulin Pump, REF: MMT-1809, MMT-1810, MMT-1817, MMT-1818, MMT-1859, MMT-1860, MMT-1867, MMT-1868\nMiniMed 740G Insulin Pump, REF: MMT-1811, MMT-1812, MMT-1861, MMT-1862", "code_info": "REF/UDI-DI(GTIN): \n\nMMT-1710/00643169568419;\n\nMMT-1750/00763000253189, 00763000375461, 00643169721319, 00643169559745, 763000253189;\n\nMMT-1714/00763000253059, 00763000074845, 00643169782396, 763000253059, 643169782396;\n\nMMT-1715/ 00763000316631, 763000190439, 763000316631;\n\nMMT-1754/00763000253066, 00643169976344, 00763000315719, 00763000381912, 763000253066;\n\nMMT-1755/643169752726, 643169873841, 763000190446, 763000101527, 763000317591, 00763000317591, 763000367091, 763000179632, 763000317621, 643169878648, 763000157043, 76300031759103, 00643169752726, 76300031759101, 76300031762103, 76300031762101, 00763000101527, 00763000190446;\n\nMMT-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;\n\nMMT-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;\n\nMMT-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, 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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;\n\nMMT-1809/00763000484644, 00763000541330, 00763000769413;\n\nMMT-1810/00763000484651, 00763000541347, 00763000769420, 00763000496302;\n\nMMT-1859/00763000505196, 00763000505257, 00763000505219, 00763000505318, 00763000505226, 00763000505288, 00763000505271, 00763000505233, 00763000505295;\n\nMMT-1860/00763000505387, 00763000505332, 00763000505370, 00763000531171, 00763000505394, 00763000505400, 00763000854768, 00763000505356, 00763000505349, 00763000505325;\n\nMMT-1867/00763000638016;\n\nMMT-1811/00763000629984, 00763000769451;\n\nMMT-1812/00763000484637, 00763000629991, 00763000769468;\n\nMMT-1861/00763000504922, 00763000504977, 00763000559557, 00763000504915, 00763000505028, 00763000504960, 00763000504984, 00763000504892, 00763000504861, 00763000504991, 00763000504953, 00763000504908, 00763000504946, 00763000505042, 00763000505004, 00763000505059, 00763000851224, 00763000851217, 00763000504939, 00763000504878;\n\nMMT-1862/00763000505080, 00763000505127, 00763000505110, 00763000505158, 00763000505172, 00763000505073, 00763000505066, 00763000505134, 00763000505103, 00763000505189, 00763000505141, 00763000505097, 00763000505165.\n\nAll serial numbers.", "firm_fei_number": "3003166194", "recalling_firm": "Medtronic MiniMed, Inc.", "address_1": "18000 Devonshire St", "city": "Northridge", "state": "CA", "postal_code": "91325-1219", "additional_info_contact": "Medtronic 24-Hr Technical Support\n800-646-4633", "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.", "root_cause_description": "Device Design", "action": "On 7/31/24, Safety Alert notices were sent to customers, healthcare professionals, distributors who were told the following:\n\n1) Always pay attention to alerts and alarms displayed on your pump.\n- Low Battery Pump alert will display when your pump has up to 10 hours of battery life left.\n- Replace Battery alert will display when the pump has less than 30 minutes of battery life left. If the battery is not replaced within 10 minutes, a siren will sound and repeat once every minute until the Replace Battery Now alarm is displayed. At that time, the pump will stop insulin delivery. If the battery is not replaced within 10 minutes of this alarm, a siren will sound, and the pump will shut down.\n2) If your pump has been dropped, bumped, or has experienced physical impact, pay special attention to any pump alerts and alarms, including low battery alerts, as they may occur earlier than expected.\n3) Pump's battery level is on the status bar located on the pump home screen.\n4) Refer to the pump user guide for instructions on how to replace the battery. \n5) If you notice any significant changes in battery life or need additional troubleshooting assistance, the firm's Technical Support line for further help.\n6) Always have extra new AA lithium or alkaline batteries or fully charged NiMH\nbatteries available, along with your other emergency kit supplies.\n7) Complete and return the confirmation form by visiting https://info.medtronicdiabetes.com/battery-statusacknowledgement\n\nIn addition, distribution partners and service providers were provided with a patient letter they could use to inform customers/pump users.\n\nIf you have further questions or need assistance, please call the firm's 24-Hour Technical Support line at 800-646-4633, option 1.", "product_quantity": "234,360", "distribution_pattern": "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.\n\nOUS: Worldwide", "openfda": { "pma_number": [ "P140015", "P130007" ], "registration_number": [ "3013756811", "2030598", "2032227", "2134850", "3007981285", "3042027705" ], "fei_number": [ "3003007876", "3013756811", "3003166194", "1000518731", "3007981285", "3042027705" ], "device_name": "Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ] }