FDAFDA · Food and drugs·Recall number Z-1749-2026
Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
Published April 8, 2026 · Recall initiated: February 13, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic MiniMed, Inc.
- Distributor
- 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.
- Lot
- 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, 00613994266880, 00613994267207, 00613994310866, 00613994310811, 00613994310781, 00613994310873, 00613994310613, 00613994310910, 00613994310880, 00613994310767, 00613994375025, 00613994368638, 00613994368553, 00613994368560, 00613994405937, 00613994368539, 00613994368546, 00613994377586, 00613994368591, 00613994368584, 00613994368577, 00613994402585, 00613994402561, 00613994401588, 00613994929815, 00643169221970, 00763000069247, 00763000090654, 00763000640163, 00613994601629, 00643169354975, 00613994401977, 00763000084332, 00643169919389, 00763000161118, 00763000161071: Artwork, CRB D Process, Instr, 522/722, NA(MP6025250-013DOC); Artwork, CRB D Process, Paradigm¿ 522 and 722 Insulin Pumps User(MP6025681-022DOC); Artwork, CRB A Process, Instr, 522/722,Block Mode,TST,Nordic,EN(MP6025681-023DOC); Artwork, CRB D Process, Instr, 522/722 with Enlite, OUS, EN(MP6025646-021DOC); Artwork, CRB D Process, Instr, 522/722, w/Enlite, OUS, EN(MP6025646-022DOC); Artwork, CRB A Process, Instr, 522/722, w/Enlite, OUS, EN(MP6025646-023DOC); Artwork, CRB A Process, Instr, 522/722, w/Enlite, OUS, EN(MP6025646-023DOC); Artwork, New Product, Feature (Form, Fit, or Function), Regulatory, Technical Literature, CRB; IFU, MMT-522/722 PRDGM X22 PUMP W/ENLITE, EN, OUS(MP6025646-024DOC); Artwork, New Product, Feature (Form, Fit, or Function), Regulatory, Technical Literature, CRB; IFU, MMT-522/722 PRDGM X22 PUMP W/ENLITE, EN, OUS(MP6025646-024DOC); Artwork, New Product, Feature (Form, Fit, or Function), Regulatory, Technical Literature, CRB; IFU, MMT-522/722 PRDGM X22 PUMP W/ENLITE, EN, OUS - Nordic cover (MP6025681-024DOC);
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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