The Recall Desk
HighFDA (Devices)·Z-1260-2025·Announced 2025-03-12

Medtronic MiniMed Insulin Pumps Recalled for Abnormal Delivery During Air Pressure Changes

Medtronic is recalling MiniMed insulin pumps that malfunction during airplane takeoff and landing due to air pressure changes. The defect can cause abnormal insulin delivery, leading to severe hypoglycemia, hyperglycemia, 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 with an identified defect in insulin pumps that can result in serious outcomes including hypoglycemia, hyperglycemia, seizure, coma, diabetic ketoacidosis, or death. No hospitalizations or injuries are reported in the source, placing this in the High severity category per the rubric criteria.

Plain-English summary

Medtronic MiniMed, Inc. is recalling approximately 168,240 units of MiniMed insulin pumps, including Paradigm series, Minimed 530G, 6XX series, and 7XX series models. The pumps are distributed worldwide, including throughout the United States.

The pumps were found to have a defect causing abnormal insulin delivery in response to air pressure changes that occur during airplane takeoff and landing. During takeoff, the pressure changes can trigger an unexpected additional dose of insulin. During landing, the pressure changes can result in unexpected under-delivery of insulin.

An unexpected additional insulin dose can cause severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin can cause severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. Patients who use affected pumps while flying are at risk for these serious outcomes.

If you use an affected MiniMed insulin pump, contact Medtronic MiniMed, Inc. for guidance. Do not use the pump during air travel until you receive replacement or alternative instructions from the manufacturer. Patients should consult with their healthcare provider about safe insulin delivery options during flights.

The recalled product

Product
MiniMed insulin pump, REF: 640G (MMT-1711, MMT-1712, MMT-1751, MMT-1752)
Manufacturer
Medtronic MiniMed, Inc.
Category
Medical Device — Insulin Pump
Hazard
  • insulin-delivery-defect
  • hypoglycemia
  • hyperglycemia
  • seizure
  • 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