Medtronic MiniMed, Inc. recalls Paradigm REAL-Time Insulin Pump

Recalling company

Medtronic MiniMed, Inc.

Product

Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)

Reason

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Feb 13, 2026

Reported

Apr 8, 2026

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.

Status

Ongoing

Quantity

29,074

Lot / codes

Pump: UDI-DI(GTIN): User Guide Name(Part-Version): Paradigm Real-Time Insulin Pump: 00613994409423, 00613994622600, 613994622747, 613994407733, 00613994407740, 00613994136374, 00613994271600, 00613994106476, 00613994373120, 00613994409478, 00613994312426, 00613994151780, 00885074419831, 00613994622747, 00613994951502, 00613994622648, 00643169026100, 00613994622624, 00613994622556, 00613994402011, 00613994409553, 00613994368485, 00613994368508, 00613994368522, 00613994108739, 00613994368607, 00613994368492, 00613994368515, 00613994123084, 00613994124814, 00613994402523, 00613994402530, 00613994402516, 00613994401502, 00613994402509, 00613994405913, 00613994123206, 00643169688421, 00643169199699, 00643169199675, 00613994409461, 00613994124777, 00643169572492, 00613994267177, 00643169848054, 00613994266897, 00613994310804, 00613994310798, 00613994310774, 00613994310903, 00613994401564, 00613994401663, 00613994402554, 00613994402462, 00613994402592, 00613994402608, 00613994405944, 00613994402455, 00613994402547, 00613994402479, 00763000069292, 00613994402578, 00613994409447, 00643169729438, 00763000069254, 00763000084325, 00613994402486, 00613994405920, 00763000069261, 00613994948595, 00613994929778, 00613994224569, 00613994929808, 00613994930361, 00613994929761, 00643169199705, 00643169199668, 00643169496248, 00643169848016, 00643169848023, 00763000161095,00613994123329, 00613994125026, 00613994247728, 00613994124692, 00613994124739, 00613994266903, 00613994267153, 006139942668

Company location

Northridge, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-1749-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1749-2026 in the FDA Enforcement Report. Also see FDA recall press releases.