Medtronic MiniMed, Inc. — MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- February 13, 2026
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.
What's affected?
- Product
- MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
- Lot code
- Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 630G Insulin Pump: 763000253066, 643169752726, 763000101527, 763000190446, 763000317591, 763000157043, 643169752726, 763000101527, 763000190446, 763000317591, 643169873841, 643169878648, 763000179632, 76300031759101, 76300031759103, 76300031762103, 763000367091, 763000317621, 763000157043, 76300031762101: MiniMed 630G System(M020092C004 1); MINIMED 630G and MINIMED 670G INSULIN PUMP SYSTEM(M042888C002 1); MiniMed 630G Insulin pump MODEL MMT-1714(M993428A262 1); MiniMed 630G System User Guide(M020092C001 3, M020092C003 1, M020092C005 1); MINIMED 630G SYSTEM USER GUIDE mg/dL(M979512A011 1); MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE(MP6026120-262 1); MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE(M030278C001 3, M030278C002 1); MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE mmol/L (MP6026120-024 1); MiniMed Veo with Enlite Threshold Suspend Performance(M10577668A262 1).
Additional details
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 630G Insulin Pump: 763000253066, 643169752726, 763000101527, 763000190446, 763000317591, 763000157043, 643169752726, 763000101527, 763000190446, 763000317591, 643169873841, 643169878648, 763000179632, 76300031759101, 76300031759103, 76300031762103, 763000367091, 763000317621, 763000157043, 76300031762101: MiniMed 630G System(M020092C004 1); MINIMED 630G and MINIMED 670G INSULIN PUMP SYSTEM(M042888C002 1); MiniMed 630G Insulin pump MODEL MMT-1714(M993428A262 1); MiniMed 630G System User Guide(M020092C001 3, M020092C003 1, M020092C005 1); MINIMED 630G SYSTEM USER GUIDE mg/dL(M979512A011 1); MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE(MP6026120-262 1); MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE(M030278C001 3, M030278C002 1); MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE mmol/L (MP6026120-024 1); MiniMed Veo with Enlite Threshold Suspend Performance(M10577668A262 1).
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 60,880.
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