The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1264-2025·Announced 2025-03-12

MiniMed Insulin Pump Models Recalled for Abnormal Delivery During Flight

Medtronic is recalling MiniMed insulin pumps due to air pressure changes during airplane takeoff and landing that can cause abnormal insulin delivery. Overdoses risk severe hypoglycemia; underdoses risk severe hyperglycemia and diabetic ketoacidosis.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is a Class II recall for a life-critical medical device with potential for serious harm including seizures, coma, and death, but no actual illnesses or hospitalizations have been reported, fitting the rubric criterion for high-severity risk-of-harm products without reported injury.

Plain-English summary

Medtronic MiniMed, Inc. is recalling MiniMed insulin pumps (Paradigm series, 530G, 6XX series, and 7XX series) due to abnormal insulin delivery triggered by air pressure changes during airplane takeoff and landing.

The affected pumps total approximately 15,439 units and have been distributed worldwide across all US states and numerous countries. During takeoff, affected pumps may deliver an unexpected additional dose of insulin, which can result in severe hypoglycemia, altered mental status, seizures, coma, or death. During landing, affected pumps may deliver less insulin than expected, which can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.

The recalled product

Product
MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
Manufacturer
Medtronic MiniMed, Inc.
Category
Medical Device — Insulin pump
Hazard
Affected units
15,439

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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