The Recall Desk
HighFDA (Devices)·Z-1266-2025·Announced 2025-03-12

Medtronic MiniMed insulin pumps may deliver abnormal insulin doses during flight

Medtronic MiniMed insulin pumps may deliver abnormal doses of insulin during airplane takeoff or landing due to air pressure changes. This can result in severe hypoglycemia or hyperglycemia, with potential for seizure, coma, or death.

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: FDA Class II recall of a medical device with identified risk of severe harm (seizure, coma, death) with no illnesses or injuries reported to date. The specific hazard—air pressure sensitivity during flight—creates a known risk pathway for users, but without manifest injury meets the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic MiniMed insulin pumps (Paradigm series, MiniMed 530G, 6XX series, and 7XX series) are being recalled due to potential abnormal insulin delivery. Approximately 329,025 units have been distributed worldwide, including throughout the United States.

The pumps have been found to be sensitive to changes in air pressure, which occur during airplane takeoff and landing. This sensitivity can cause unexpected delivery errors: over-delivery during takeoff and under-delivery during landing.

Over-delivery of insulin can result in severe hypoglycemia, altered mental status, seizure, coma, or death. Under-delivery of insulin can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

The recalled product

Product
MiniMed insulin pump, REF: 780G (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)
Manufacturer
Medtronic MiniMed, Inc.
Category
Medical Device — Insulin pump
Hazard
Affected units
329,025

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 (2)

  • All Lot Numbers
  • All UDI numbers

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 12 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 12 products in this recall →

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Same manufacturer · Medtronic MiniMed, Inc.

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