The Recall Desk
HighFDA (Devices)·Z-1258-2025·Announced 2025-03-12

MiniMed Insulin Pumps Recalled for Abnormal Delivery During Air Travel

Medtronic recalled MiniMed insulin pumps due to abnormal delivery caused by air pressure changes during airplane flights. The defect can cause severe hypoglycemia or hyperglycemia, potentially leading to 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 medical device with identified serious potential consequences including seizure, coma, and death when exposed to air pressure changes. No incidents are reported in the recall notice, meeting the criteria for risk-of-harm products where injury has not yet been confirmed.

Plain-English summary

Medtronic MiniMed has recalled certain insulin pumps that can deliver incorrect doses of insulin when exposed to changes in air pressure, particularly during airplane takeoff and landing. The affected models include the Paradigm series, MiniMed 530G, and 6XX and 7XX series pumps. A total of 228 units have been affected by this recall, which has worldwide distribution including all 50 US states and numerous international countries.

During airplane takeoff, an unexpected additional dose of insulin can be delivered, which can cause severe hypoglycemia (dangerously low blood sugar), altered mental status, seizure, coma, or death. During landing, an unexpected under-delivery of insulin can occur, which can result in severe hyperglycemia (high blood sugar), dehydration, diabetic ketoacidosis, or death.

Patients who use these pumps should be aware of this risk, particularly when traveling by air. Medtronic recommends consulting with healthcare providers about managing insulin delivery during air travel. Patients should not discontinue their insulin therapy but should work with their medical team to address this safety concern.

The recalled product

Product
MiniMed insulin pump, REF: 620G (MMT-1750)
Manufacturer
Medtronic MiniMed, Inc.
Category
Medical Device — Insulin Pump
Hazard
  • abnormal-insulin-delivery
  • severe-hypoglycemia
  • severe-hyperglycemia
  • diabetic-ketoacidosis

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.

Related recalls

Same category