MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
Enforcement
- Recall Number
- Z-1742-2026
- Event ID
- 98186
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medtronic MiniMed, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 8, 2026
- Initiation Date
- February 13, 2026
- Classification Date
- April 2, 2026
- Address
- 18000 Devonshire St, Northridge, CA, 91325-1219, United States
Description
MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
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.
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 770G Insulin Pump: 763000456634, 763000414344, 763000413750, 763000545604, 763000586188, 763000642242, 763000926113, 763000482602, 763000416553, 763000439903, 763000416546, 763000439910, 763000629892, 763000629908, 00763000595906, 763000412685, 763000418151, 763000416546, 763000439903, 763000545499, 763000595906, 763000545505, 763000629892, 763000642235, 763000414344, 763000413750, 763000439866, 763000413750, 763000586195, 763000545604, 763000578640, 76300058618802, 76300058619501, 76300057864002, 76300054560402, 76300058619502, 763000926113: For MiniMed 770G System Users Ages 2-13(M010831C001 1); MiniMed 770G SYSTEM USER GUIDE(M984970A002 1, M978700A002 1, M030281C001 3, M030281C002 1, M811470A261 2, M984970A004 1, M020090C001 3, M020090C002 1, M020090C003 1, M998590A012 2, M998590A003 1, M998590A004 1); MiniMed 770G SYSTEM USER GUIDE mmol/L(M000039C021 1, M811470A021 2).
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.
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