Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump (MMT-1760, MMT-1761, MMT-1762, MMT

Hazard / Issue

All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 670G Insulin Pump: 643169946057, 763000096984, 763000090203, 763000165468, 763000190460, 763000190453, 763000216481, 763000187422, 763000187415, 763000165413, 763000165475, 763000367657, 763000289065, 763000264710, 763000283476, 763000283544, 763000283520, 763000283445, 763000393786, 763000289058, 763000374532, 763000283537, 763000365899, 763000371937, 763000283513, 763000165451, 763000165420, 763000165444, 763000165437, 763000165499, 763000165482, 763000165536, 763000165512, 763000165550, 763000165529, 763000235772, 763000165505, 763000235765, 763000165543, 763000257309, 763000283568, 763000283599, 763000289041, 763000289089, 763000289195, 763000289072, 763000289119, 763000289188, 763000289133, 763000289126, 763000289171, 763000289102, 763000404543, 763000289096, 763000289164, 763000404536, 763000324797, 763000264727, 763000324780, 763000283551, 763000283582, 763000374518, 763000374525, 763000374556, 763000374624, 763000374594, 763000374600, 763000399849, 763000399856, 763000408916, 763000408947, 763000371944, 763000365905, 763000374587, 763000408930, 763000283575, 763000157463, 763000203313, 763000252076, 763000283506, 763000411787, 643169946057, 763000096984, 763000190453, 763000283445, 763000395858, 763000278427, 763000090203, 763000283513, 763000365882, 763000283506, 76300028351303, 763000393786, 76300028351301, 763000166526, 643169939202, 763000190460, 763000283520, 763000072537, 763000256821, 643169939219, 763000187415, 763000283568: MiniMed670G System User Guide(M979513A011 1); MINIMED 630G and MINIMED 670G INSULIN PUMP SYSTEM(M042888C002 1); MINIMED 670G SYSTEM USER GUIDE(M988666A021 1, M979513A011 1, M985214A021 1, M985214A261 1, M974439A181 1, M974439A062 1, M974439A032 1, M974439A043 1, M974439A073 1, M974439A103 1, M974439A052 1, M020098C001 3, M020098C003 1, M974439A165 1, M974439A093 1, M974439A083 1); MINIMED 670G SYSTEM USER GUIDE mg/dL(M974449A111 1, M974449A073 1, M974449A103 1, M974449A023 1, M974449A093 1, M974449A083 1, M974449A113 1); MINIMED 670G SYSTEM USER GUIDE mmol/L(M974439A024 1).