Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)
Pending LLM rewrite. Source: FDA_DEVICE Z-1752-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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