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FDAHealthFebruary 13, 2026

Medtronic MiniMed, Inc. — Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)

⚠️ 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
Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)
Lot code
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): Paradigm Veo: 00613994717801, 00613994713834, 00613994713841, 00613994870414, 00613994870377, 00613994870407, 00643169378636, 00613994924957, 00613994717672, 00613994715531, 00613994715555, 00613994715562, 00613994409423, 00613994951502, 00643169026131, 00613994622600, 00613994407740, 00643169077737, 00643169464537, 00643169305038, 00643169500259, 00643169503229, 00643169528789, 00643169533776, 00613994151766, 00643169711440, 00763000084370, 00763000161224, 00763000161262, 00643169464520, 00613994963376, 00643169026100, 00613994924247, 00643169299757, 00643169400931, 00643169400986, 00643169535749, 00643169535794, 00643169519190, 00643169579507, 00643169519091, 00763000084349, 00763000084356, 00763000161248, 00763000048853, 00763000161231, 00643169729445, 00643169846036, 00643169579453, 00613994714183, 00613994716156, 00613994657671, 00643169515741, 00643169579514, 00643169579538, 00643169579477, 00643169579569, 00643169579392, 00643169579583, 00643169579552, 00643169579576, 00643169846012, 00643169845909, 00643169845947, 00643169845992, 00643169846043, 00763000067663, 00643169846005, 00763000001247, 00643169578470, 00763000059729, 00763000048860,00763000048914, 00763000048839, 00763000048884, 00763000048822, 00763000048808, 00763000048938, 00763000048815, 00763000048921, 00763000048891, 00763000048785, 00763000048945, 00763000048877, 00763000048846, 00613994924438, 00613994924223, 00613994924391, 00613994924339, 00613994924346, 00613994924216, 00613994924278, 00763000084387, 00643169196766, 00613994611697, 00613994715944, 00613994714190, 00613994716002, 00613994716248, 00613994717719, 00613994716194, 00613994716361, 00613994716422, 00613994716415, 00613994716200, 00613994716354, 00613994716187, 00613994716323, 00613994716408, 00613994716385, 00613994716378, 00613994716217, 00613994863560, 00613994863515, 00613994863607, 00613994863409, 00613994863614, 00613994863355, 00613994863393, 00613994863430, 00613994863416, 00613994863553, 00613994863577, 00613994863539, 00613994863584, 00613994974273, 00613994870278, 00613994863621, 00613994924032, 00613994924254, 00613994863638, 00613994924353, 00613994924414, 00613994924445, 00613994863522, 00613994924407, 00613994863546, 00613994924384, 00613994924230, 00613994924421, 00613994750969, 00643169196674, 00643169196612, 00643169196704, 00643169196735, 00643169196698, 00643169196711, 00643169196773, 00643169196681, 00643169196728, 00643169196759, 00643169196742, 00643169196780, 00643169196636, 00643169196650, 00643169341654, 00643169317550, 00643169317574, 00643169317611, 00643169317567, 00643169317659, 00643169317642, 00643169317666, 00643169317536, 00643169306912, 00643169317581, 00643169341647, 00643169341661, 00643169324039, 00643169318960, 00643169317604, 00643169317598, 00643169317628, 00643169341630, 00643169324084, 00643169326668, 00643169317635, 00643169319370, 00643169381827, 00643169378995, 00643169379008, 00643169381810, 00643169378988, 00643169381780, 00643169381834, 00643169381773, 00643169381889, 00643169381872, 00643169381803, 00643169381797, 00643169381896, 00643169381766, 00643169381841, 00643169381902, 00643169428232, 00643169383838, 00643169379572, 00643169378704, 00643169411692, 00643169382725, 00643169495593, 00643169381865, 00763000084363, 00643169376090, 00643169579545, 00643169579521, 00643169593404, 00643169579439, 00643169579415, 00643169579484, 00643169579491, 00643169742048, 00643169579408, 00643169579422, 00643169845985, 00763000161279, 00763000217396, 00643169845954, 00643169845930, 00643169846067, 00643169846050, 00643169845961, 00643169846029, 00763000161255, 00643169845923, 00763000048907, 00763000048792: Labeling/Packaging; INSTR, INSULIN PUMP 554/754 (6025362 1) INSTRUCTIONS FOR USE, 554/754, DE (6025362-071 4); INSTR,INSULIN PUMP, 554/754 (6025362-022 7); INSTR,INSULIN PUMP, 554/754 (6025362-021 2); INSTR, 554/754, EN, A52 (6025362-024 1); INSTR. FOR USE, 554/754, EN (6025362-023 2); INSTR., INSULIN PUMP, 554/754 (6025362-026 3); INSTR, 554/754, EN (6025362-025 2); Artwork, New Product, Feature, (Form, Fit, or Function), Regulatory, Technical Literature, CRB; IFU, MMT-554/754 PRDGM VEO PUMP W/ENLITE, Nordic Cover, EN, OUS (MP6025679-025 1); Artwork, CRB D Process; Instr, X54, Paradigm, Nordic, EN (MP6025679-023 3); Artwork, CRB A Process; Instr, X54, Paradigm, Nordic, EN (MP6025679-024 1)

Additional details

Pump: UDI-DI(GTIN): User Guide Name(Part-Version): Paradigm Veo: 00613994717801, 00613994713834, 00613994713841, 00613994870414, 00613994870377, 00613994870407, 00643169378636, 00613994924957, 00613994717672, 00613994715531, 00613994715555, 00613994715562, 00613994409423, 00613994951502, 00643169026131, 00613994622600, 00613994407740, 00643169077737, 00643169464537, 00643169305038, 00643169500259, 00643169503229, 00643169528789, 00643169533776, 00613994151766, 00643169711440, 00763000084370, 00763000161224, 00763000161262, 00643169464520, 00613994963376, 00643169026100, 00613994924247, 00643169299757, 00643169400931, 00643169400986, 00643169535749, 00643169535794, 00643169519190, 00643169579507, 00643169519091, 00763000084349, 00763000084356, 00763000161248, 00763000048853, 00763000161231, 00643169729445, 00643169846036, 00643169579453, 00613994714183, 00613994716156, 00613994657671, 00643169515741, 00643169579514, 00643169579538, 00643169579477, 00643169579569, 00643169579392, 00643169579583, 00643169579552, 00643169579576, 00643169846012, 00643169845909, 00643169845947, 00643169845992, 00643169846043, 00763000067663, 00643169846005, 00763000001247, 00643169578470, 00763000059729, 00763000048860,00763000048914, 00763000048839, 00763000048884, 00763000048822, 00763000048808, 00763000048938, 00763000048815, 00763000048921, 00763000048891, 00763000048785, 00763000048945, 00763000048877, 00763000048846, 00613994924438, 00613994924223, 00613994924391, 00613994924339, 00613994924346, 00613994924216, 00613994924278, 00763000084387, 00643169196766, 00613994611697, 00613994715944, 00613994714190, 00613994716002, 00613994716248, 00613994717719, 00613994716194, 00613994716361, 00613994716422, 00613994716415, 00613994716200, 00613994716354, 00613994716187, 00613994716323, 00613994716408, 00613994716385, 00613994716378, 00613994716217, 00613994863560, 00613994863515, 00613994863607, 00613994863409, 00613994863614, 00613994863355, 00613994863393, 00613994863430, 00613994863416, 00613994863553, 00613994863577, 00613994863539, 00613994863584, 00613994974273, 00613994870278, 00613994863621, 00613994924032, 00613994924254, 00613994863638, 00613994924353, 00613994924414, 00613994924445, 00613994863522, 00613994924407, 00613994863546, 00613994924384, 00613994924230, 00613994924421, 00613994750969, 00643169196674, 00643169196612, 00643169196704, 00643169196735, 00643169196698, 00643169196711, 00643169196773, 00643169196681, 00643169196728, 00643169196759, 00643169196742, 00643169196780, 00643169196636, 00643169196650, 00643169341654, 00643169317550, 00643169317574, 00643169317611, 00643169317567, 00643169317659, 00643169317642, 00643169317666, 00643169317536, 00643169306912, 00643169317581, 00643169341647, 00643169341661, 00643169324039, 00643169318960, 00643169317604, 00643169317598, 00643169317628, 00643169341630, 00643169324084, 00643169326668, 00643169317635, 00643169319370, 00643169381827, 00643169378995, 00643169379008, 00643169381810, 00643169378988, 00643169381780, 00643169381834, 00643169381773, 00643169381889, 00643169381872, 00643169381803, 00643169381797, 00643169381896, 00643169381766, 00643169381841, 00643169381902, 00643169428232, 00643169383838, 00643169379572, 00643169378704, 00643169411692, 00643169382725, 00643169495593, 00643169381865, 00763000084363, 00643169376090, 00643169579545, 00643169579521, 00643169593404, 00643169579439, 00643169579415, 00643169579484, 00643169579491, 00643169742048, 00643169579408, 00643169579422, 00643169845985, 00763000161279, 00763000217396, 00643169845954, 00643169845930, 00643169846067, 00643169846050, 00643169845961, 00643169846029, 00763000161255, 00643169845923, 00763000048907, 00763000048792: Labeling/Packaging; INSTR, INSULIN PUMP 554/754 (6025362 1) INSTRUCTIONS FOR USE, 554/754, DE (6025362-071 4); INSTR,INSULIN PUMP, 554/754 (6025362-022 7); INSTR,INSULIN PUMP, 554/754 (6025362-021 2); INSTR, 554/754, EN, A52 (6025362-024 1); INSTR. FOR USE, 554/754, EN (6025362-023 2); INSTR., INSULIN PUMP, 554/754 (6025362-026 3); INSTR, 554/754, EN (6025362-025 2); Artwork, New Product, Feature, (Form, Fit, or Function), Regulatory, Technical Literature, CRB; IFU, MMT-554/754 PRDGM VEO PUMP W/ENLITE, Nordic Cover, EN, OUS (MP6025679-025 1); Artwork, CRB D Process; Instr, X54, Paradigm, Nordic, EN (MP6025679-023 3); Artwork, CRB A Process; Instr, X54, Paradigm, Nordic, EN (MP6025679-024 1)

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 55,724.

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