Class II U.S. Food and Drug Administration

Medtronic MiniMed, Inc. MiniMed 770G Insulin Pump recall: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series

Recall published 7 months ago

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 hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1742-2026
Published
April 8, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medtronic MiniMed, Inc.
Product type
Medical devices
Units affected
95,704
Distribution
Nationwide
Made in
United States
Lot / code info
Pump: UDI-DI(GTIN): User Guide Name(Part-Version): MiniMed 770G Insulin Pump: 763000456634, 763000414344, 763000413750, 763000545604, 763000586188, 763000642242, 763000926113, 763000482602, 763000416553, 763000439903, 763000416546, 763000439910, 763000629892, 763000629908, 00763000595906, 763000412685, 763000418151, 763000416546, 763000439903, 763000545499, 763000595906, 763000545505, 763000629892, 763000642235, 763000414344, 763000413750, 763000439866, 763000413750, 763000586195, 763000545604, 763000578640, 76300058618802, 76300058619501, 76300057864002, 76300054560402, 76300058619502, 763000926113: For MiniMed 770G System Users Ages 2-13(M010831C001 1); MiniMed 770G SYSTEM USER GUIDE(M984970A002 1, M978700A002 1, M030281C001 3, M030281C002 1, M811470A261 2, M984970A004 1, M020090C001 3, M020090C002 1, M020090C003 1, M998590A012 2, M998590A003 1, M998590A004 1); MiniMed 770G SYSTEM USER GUIDE mmol/L(M000039C021 1, M811470A021 2).
UPC codes
763000456634, 763000414344, 763000413750, 763000545604, 763000586188, 763000642242, 763000926113, 763000482602, 763000416553, 763000439903, 763000416546, 763000439910, 763000629892, 763000629908, 00763000595906, 763000412685, 763000418151, 763000545499, 763000595906, 763000545505

Products covered by this recall

MiniMed 770G Insulin Pump (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)

Check your product

The notice names 20 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 763000456634
  • 763000414344
  • 763000413750
  • 763000545604
  • 763000586188
  • 763000642242
  • 763000926113
  • 763000482602
  • 763000416553
  • 763000439903
  • 763000416546
  • 763000439910
  • 763000629892
  • 763000629908
  • 00763000595906
  • 763000412685
  • 763000418151
  • 763000545499
  • 763000595906
  • 763000545505

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medtronic MiniMed, Inc. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Medtronic MiniMed, Inc. — 18000 Devonshire St, Northridge, CA, 91325-1219

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medtronic MiniMed, Inc. medical devices 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 763000456634, 763000414344, 763000413750. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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