The Recall Desk
Severity pendingFDA (Devices)·Z-1750-2026·Announced 2026-04-08

Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)

Pending LLM rewrite. Source: FDA_DEVICE Z-1750-2026.

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 Revel Insulin Pump (MMT-523, MMT-723)
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 (17)

  • 00763000161262
  • 00613994743930
  • 00643169077737
  • 00613994904485
  • 00643169202399
  • 00643169151369
  • 00643169478602
  • 00643169513914
  • 00643169933170
  • 00763000161132
  • 00643169464520: Artwork
  • CRB D Process
  • Paradigm REAL-Time Revel Insulin Pump UG (MP6025306-011A 1)
  • Artwork
  • Instr
  • X23 revel
  • EN (MP6025306-019 1)

Distribution

Distributed nationwide across the United States.

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