Medtronic MiniMed, Inc. recalls MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, 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 780G Insulin Pump: 763000411541, 763000441449, 763000523305, 763000521530, 763000521516, 763000533861, 763000544317, 763000734459, 763000758530, 763000758547, 763000578688, 763000734435, 763000504762, 763000734466, 763000924102, 763000924089, 763000454296, 763000854829, 763000411411, 763000411503, 763000384272, 763000411466, 763000411428, 763000411572, 763000411589, 763000411558, 763000384265, 763000411473, 763000411374, 763000411435, 763000411404, 763000384289, 763000411459, 763000411510, 763000411626, 763000411565, 763000411527, 763000411619, 763000411596, 763000411497, 763000411398, 763000411534, 763000411381, 763000384258, 763000411480, 763000411602, 763000411640, 763000411442, 763000441432, 763000442194, 763000521523, 763000442187, 763000521509, 763000521547, 763000578671, 763000596194, 763000639228, 763000639235, 763000639266, 763000974381, 763000974374, 763000921750, 763000921767, 763000921590, 763000921637, 763000933593, 763000891886, 763000921729, 763000921866, 763000921781, 763000921811, 763000921576, 763000921583, 763000921620, 763000921859, 763000891909, 763000921743, 763000944162, 763000921712, 763000921668, 763000933579, 763000933555, 763000933586, 763000933609, 763000921613, 763000933715, 763000933548, 763000944209, 763000891893, 763000933623, 763000933722, 763000933814, 763000933708, 763000933777, 763000933685, 763000933531, 763000933678, 763000933821, 763000933746, 763000933562, 763000944193, 763000533878, 763000734442, 763000854942, 763000914127: Medtronic MiniMed 780G with Instinct sensor System User Guide(M018856C024 2, M018857C035 2); Medtronic MiniMed 780G with Simplera Sync sensor System User Guide(M018857C034 2); Medtronic MiniMed 780G with Guardian 4 Sensor System User Guide(M028790C004 2, M028792C004 2); Medtronic MiniMed 780G with Guardian 4 Sensor System User Guide(M028792C015 1, M028792C001 3, M028792C002 1, M028792C006 1, M028792C003 1, M028792C005 1); Medtronic MiniMed 780G with Instinct sensor System User Guide(M018857C008 1, M018857C011 1, M018857C029 1, M018856C022 1, M018857C013 1, M018856C007 1, M018857C001 4, M018856C001 4, M018856C010 1, M018857C012 1, M018856C020 1, M018857C009 1, M018857C032 1, M018857C022 1, M018856C021 1, M018856C013 1, M018857C028 1, M018857C033 1, M018856C017 1, M018857C016 1, M018856C018 1); Medtronic MiniMed 780G with Simplera Sync sensor System User Guide(M018856C023 2, M018857C034 2); MiniMed 780G System Technical Guide(M075489C003 1, M075489C002 1, M075489C001 2); MiniMed 780G System User Guide(M072481C001 2); MiniMed 780G with Guardian 4 Sensor System User Guide mg(, M073070C003 1, M073070C001 2, M073070C002 1); MiniMed 780G with Guardian 4 Sensor System User Guide mm(M076019C002 1, M076019C001 1); MiniMed 780G with Guardian 4 Sensor System User Guide(M028790C003 1, M028790C002 1); MiniMed 780G system Changing the Medtronic Extended Infusion Set with Extended Reservoir(M048911C001 2, M048911C003 1, M048911C002 1); MiniMed 780G system Changing the MiniMed Mio Advance Infusion Set and Reservoir(M047607C001 1); MiniMed 780G system Changing the MiniMed Silhouette Infusion Set and Reservoir(M047610C001 1, M047610C003 1, M047610C002 1); MiniMed 780G system Changing the MiniMed Sure-T Infusion Set and Reservoir(M047609C001 1, M047609C003 1, M047607C003 1, M047607C002 1, M047609C002 1); MiniMed 780G System User Guide(M024832C003 2, M024829C004 2, M024832C004 2, M024829C005 2); MiniMed 780G System User Guide mg/dl(M014786C005 2, M014784C005 2, M014786C007 1, M014784C007 1, M014784C004 1, M014786C004 1, M014786C008 1, M014784C008 1, M014784C002 1, M014786C006 1, M014784C006 1, M014784C016 1, M014786C016 1, M014784C012 1, M014786C012 1, M014786C002 1, M014784C010 1, M014786C010 1, M014784C003 1, M014786C003 1, M014784C011 1, M014786C011 1, M014786C013 1, M014784C013 1, M014784C015 1, M014786C015 1, M014786C019 1, M014784C019 1); MiniMed 780G System User Guide mmol/L(M014787C002 1, M014785C002 1, M014785C007 2, M014787C007 1, M014787C005 1, M014785C005 1, M014787C006 1, M014785C006 1, M014785C023 2, M014787C023 2, M014787C010 1, M014785C010 1, M014787C011 1, M014785C011 1, M014787C021 1, M014785C021 1, M014787C008 1, M014785C008 1, M014785C009 1, M014787C009 1, M014787C022 1, M014785C022 1, M014785C027 1, M014787C027 1, M014787C004 2, M014785C004 2, M014785C003 1, M014787C003 1, M014785C030 1, M014787C030 1, M014785C013 2, M014787C013 2, M014785C019 1, M014787C019 1, M014785C020 1, M014787C020 1, M014787C018 1, M014785C018 1, M014787C012 1, M014785C012 1, M014787C016 1, M014785C016 1, M014787C024 1, M014785C024 1, M014785C014 2, M014787C014 1, M014787C028 1, M014785C028 1); MiniMed 780G with Guardian 4 Sensor System User Guide(M060264C012 1, M060263C011 1, M060264C018 1, M060263C015 1, M060264C017 1, M060263C014 1, M060264C006 1, M060264C004 1, M060263C001 3, M060263C016 1, M060264C007 1, M060264C008 1, M060264C009 1, M060264C010 1, M060264C011 1, M060264C001 3, M060264C013 1, M060264C014 1, M060264C023 1, M028790C005 1, M060263C020 1, M060264C015 1, M060264C016 1, M060264C020 1, M060263C021 1, M028790C006 1, M060263C022 1, M056377C001 3, M056377C003 1, M056377C002 1, M060263C023 1, M060264C021 1, M060264C022 1, M060263C024 1); MiniMed 780G with Guardian 4 Sensor System User Guide mg/dl(M028790C001 3, M028790C011 1, M028790C007 1, M028790C008 1, M028790C010 1, M028790C019 1); MiniMed 780G with Guardian 4 Sensor System User Guide mmol/L(M028792C012 1, M028792C013 1, M028792C007 1, M028792C011 1, M028792C025 1, M028792C014 1, M028792C001 3, M028792C033 1, M028792C010 1); MiniMed 780G with Instinct sensor System User Guide(M018857C004 1); MiniMed 780G with Simplera Sync sensor System User Guide(M060262C008 1, M060261C002 1, M018857C003 1, M018856C003 1, M060262C015 1, M018856C005 1, M060261C004 1, M060261C003 1, M018856C006 1, M060262C014 1, M060262C002 1, M060261C001 3, M060261C005 1, M060262C003 1, M060262C004 1, M060262C005 1, M060262C006 1, M060262C007 1, M060262C001 3, M060262C009 1, M018857C015 1, M060262C010 1, M018856C009 1, M060261C009 1, M060262C021 1, M018857C034 2, M060262C012 1, M060262C013 1, M060262C016 1, M018856C012 1, M060261C010 1, M060261C011 1, M056047C001 3, M056047C003 1, M056047C002 1, M060261C012 1, M060262C019 1, M060262C020 1, M060261C013 1); MiniMed 780G with the Guardian 4 Sensor System User Guide(M036461C004 2, M036461C001 2, M036461C007 1, M036461C003 1, M036461C002 1, M036461C006 1); MiniMed 780G with the Guardian Sensor (3) System User Guide(M010682C005 2, M010682C008 1); MiniMed 780G with the Guardian Sensor 3 System User Guide(M010682C002 2, M010682C004 1, M010682C007 1, M010682C003 1)