The Recall Desk
HighFDA (Devices)·Z-1259-2025·Announced 2025-03-12

MiniMed Insulin Pumps Recalled for Abnormal Insulin Delivery During Flight

MiniMed insulin pumps may deliver abnormal insulin doses during aircraft takeoff and landing due to air pressure changes, risking severe blood sugar fluctuations, seizures, and potentially fatal complications.

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 critical insulin delivery device with potential for severe, life-threatening outcomes including death, seizures, and diabetic ketoacidosis. No actual illnesses or deaths are documented in the source text.

Plain-English summary

Medtronic MiniMed is recalling MiniMed insulin pumps of the 630G series and related models. Approximately 70,587 units have been distributed worldwide, including throughout the United States and international markets.

The pumps contain a defect in insulin delivery related to air pressure changes that occur during aircraft takeoff and landing. During takeoff, the device may deliver an unexpected additional dose of insulin. During landing, the device may deliver less insulin than intended.

An unexpected additional dose can result in severe hypoglycemia, altered mental status, seizures, coma, or death. An unexpected under-delivery can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. Users of these pumps should be particularly cautious during air travel.

The recalled product

Product
MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
Manufacturer
Medtronic MiniMed, Inc.
Category
Medical Device — Insulin Pump
Hazard
Affected units
70,587

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 →

Related recalls

Same manufacturer · Medtronic MiniMed, Inc.

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Same hazard · abnormal insulin delivery

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