The Recall Desk
HighFDA (Devices)·Z-1749-2026·Announced 2026-04-08

Paradigm REAL-Time insulin pump delivery varies with pump height

Medtronic is recalling Paradigm REAL-Time insulin pumps because raising or lowering the pump relative to the infusion site can cause unintended over- or under-delivery of insulin.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: the source lists death among the potential consequences of the mechanism but records no reported death, injury or hospitalisation.

Plain-English summary

Medtronic MiniMed, Inc. is recalling the Paradigm REAL-Time Insulin Pump, models MMT-522 and MMT-722. About 29,074 units were distributed across the United States nationwide and more than eighty other countries. The FDA has classified this recall as Class II.

All Medtronic MiniMed infusion pumps, covering the 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, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Medtronic states that over-delivery can result in severe hypoglycemia, altered mental status, seizure, coma or death, and that under-delivery can result in severe hyperglycemia, dehydration, diabetic ketoacidosis or death.

Affected pumps are listed by UDI-DI and user guide part version in the FDA enforcement record.

Users and clinicians can identify affected pumps by the model numbers above, and may contact Medtronic MiniMed, Inc. for further information.

The recalled product

Product
Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722)
Manufacturer
Medtronic MiniMed, Inc.
Category
Medical Device — Insulin pump
Hazard
Affected units
29,074

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)

  • 00613994622600
  • 613994622747
  • 613994407733
  • 00613994407740
  • 00613994136374
  • 00613994271600
  • 00613994106476
  • 00613994373120
  • 00613994409478
  • 00613994312426
  • 00613994151780
  • 00885074419831
  • 00613994622747
  • 00613994951502
  • 00613994622648
  • 00643169026100
  • 00613994622624
  • 00613994622556
  • 00613994402011
  • 00613994409553

Distribution

Distributed nationwide across the United States.

The notice also names 53 states specifically:

Part of a larger recall action

This product is one of 14 recalled by Medtronic MiniMed, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

Related recalls

Same manufacturer · Medtronic MiniMed, Inc.

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Same hazard · insulin delivery error

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