Home / Recalls / Medtronic MiniMed, Inc. / Z-1257-2025

Z-1257-2025 Class II Ongoing

Recalled by Medtronic MiniMed, Inc. — Northridge, CA

Recall Details

Product Type
Devices
Report Date
March 12, 2025
Initiation Date
January 31, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
41,404 units

Product Description

Paradigm insulin pump, REF: MMT-754

Reason for Recall

All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

Distribution Pattern

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

Code Information

All Lot Numbers; All UDI numbers

Other recalls by Medtronic MiniMed, Inc.

  • Z-0958-2026 Class II — InPen App, Model/CFN Number: MMT-8061 (Android Users) (November 13, 2025)
  • Z-1238-2026 Class II — MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Ve (November 2, 2025)
  • Z-0594-2026 Class II — CareLink Clinic, REF: MMT-7350 (October 21, 2025)
  • Z-2496-2025 Class II — InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users) (June 16, 2025)
  • Z-0033-2026 Class II — Medtronic, Simplera Sensor, REF: MMT-5100JD1 (May 7, 2025)
  • Z-1650-2025 Class II — InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-1 (March 4, 2025)
  • Z-1262-2025 Class II — MiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851) (January 31, 2025)
  • Z-1264-2025 Class II — MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862) (January 31, 2025)
  • Z-1261-2025 Class II — MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1 (January 31, 2025)
  • Z-1260-2025 Class II — MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752) (January 31, 2025)