FDA DevicesClass II
Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)
Published: April 8, 2026Recall ID: Z-1752-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)
Additional Source Details
| Field | Value |
|---|---|
| City | Northridge |
| State | CA |
| Event id | 98186 |
| Address 1 | 18000 Devonshire St |
| Code info | 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, 006431... [TRUNCATED] |
| Postal code | 91325-1219 |
| Report date | 20260408 |
| Product type | Devices |
| Product quantity | 55,724 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260213 |
| Initial firm notification | Letter |
| Center classification date | 20260402 |
Overview
- Recalling FirmMedtronic MiniMed, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.