The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1262-2025·Announced 2025-03-12

Medtronic MiniMed insulin pump recalled for abnormal delivery during air pressure changes

Medtronic MiniMed insulin pumps may deliver insulin abnormally during airplane take-off or landing due to air pressure changes, risking severe low or high blood sugar emergencies.

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 FDA Class II medical device recall involves serious potential consequences including death, seizures, and hyperglycemic emergencies, but no injuries or illnesses have been reported to date. It qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medtronic MiniMed is recalling approximately 4,959 insulin pump units (MiniMed 700G and other series). The pumps may deliver insulin incorrectly when exposed to air pressure changes that occur during airplane take-off and landing.

During take-off, the pump may deliver an unexpected additional dose of insulin, potentially causing severe low blood sugar (hypoglycemia) with serious complications including altered mental status, seizures, coma, and death.

During landing, the pump may under-deliver insulin, potentially causing dangerously high blood sugar (hyperglycemia) that can lead to dehydration, diabetic ketoacidosis, and death.

These pumps have been distributed worldwide, including throughout all U.S. states and numerous countries. The recall affects all lot numbers and UDI numbers of the affected pump models.

The recalled product

Product
MiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851)
Manufacturer
Medtronic MiniMed, Inc.
Category
Medical Device — Insulin Pump
Hazard
Affected units
4,959

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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