CLASS II ONGOING Device recall · Reported 8 Apr 2026 · FDA Enforcement Report

Paradigm Real-Time Veo Insulin Pump (Mmt-554, Mmt-754) recalled

Medtronic MiniMed is recalling Paradigm Real-Time Veo Insulin Pump (Mmt-554, Mmt-754), distributed nationwide in the US. The recall was initiated on 13 Feb 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPump: 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)
Quantity recalled55,724

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1752-2026
FDA event ID
98186
Recalling firm
Medtronic MiniMed, Northridge, CA
Classification
Class II
Status
Ongoing
Recall initiated
13 Feb 2026
FDA classified
2 Apr 2026
Reported
8 Apr 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

13 Feb 2026Recall initiated by company
2 Apr 2026Classified by FDA+48 days
8 Apr 2026Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)

Where it was distributed

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.

Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts

Questions about this recall

Is Paradigm Real-Time Veo Insulin Pump (Mmt-554, Mmt-754) recalled?

Yes. Medtronic MiniMed recalled Paradigm Real-Time Veo Insulin Pump (Mmt-554, Mmt-754) on 13 Feb 2026. The recall is Class II and its status is Ongoing. Recall number Z-1752-2026.

Why was it recalled?

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.

Which lots are affected?

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)

Where was it sold?

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 should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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