MiniMed recall

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?

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)

Product

MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)

Recalling firm

Medtronic MiniMed, Inc.

Quantity

453,144

Distribution

Worldwide - US Nationwide distribution including in the states of OR, CA, AZ, NY,TX,FL, OH, MO, TN,NJ, NC, SC, IL, VA, WA, DC, GA, PA, MS,IA, MI, NH, OK, SD, MT, WI, WV, MA, LA, MN, RI, AR, ME, AL, IN, UT, KY, CO, ND, MD, CT, NM, KS, ID, NV, DE, NE, VT, AK, HI, WY, PR, VI and the countries of Taiwan, New Zealand, Australia, Bangladesh, Brunei Darussalam, Cambodia, Indonesia, Malaysia, Maldives, Philippines, Thailand, Vietnam, Singapore, Pakistan, Hong Kong, China, Argentina, Aruba, Barbados, Bermuda, Bolivia, Plurinational State Of, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Panama, Paraguay, Peru, Puerto Rico, Trinidad And Tobago, Uruguay, Venezuela, Canada, South Korea, India, Albania, Algeria, Andorra, Armenia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Bulgaria, Canary Islands, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guyana, French Polynes., Georgia, Germany, Gibraltar, Greece, Guadeloupe, Hungary, Iceland, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Liechtenstein, Lithuania, Luxembourg, Macedonia, Malawi, Malta, Martinique, Mauritius, Mayotte, Moldavia, Montenegro, Morocco, Namibia, Netherlands, New Caledonia, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Qatar, Reunion, Romania, Russia, San Marino, Saudi Arabia, Serbia, Sierra Leone, Slovakia, Slovenia, South Africa, Spain, St.Pier,Miquel., Sudan, Sweden, Switzerland, Syrian Arab Republic, Tanzania, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Yemen, Zambia, Zimbabwe.

Recall date

April 8, 2026

Classification

Class II

Status

Ongoing

Agency

FDA (device)