The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1256-2025·Announced 2025-03-12

Medtronic Paradigm insulin pump recall for abnormal delivery during flight

Medtronic MiniMed Paradigm insulin pumps may deliver incorrect insulin doses during airplane takeoff or landing due to air pressure changes. This can cause severe high or low blood sugar requiring immediate medical attention.

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 recall involves a life-critical device with potential for serious complications including seizures, coma, and death. Although no injuries have been reported, the serious nature of potential harms during high-risk situations justifies a High classification per the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medtronic MiniMed is recalling Paradigm series insulin pumps due to a defect that causes abnormal insulin delivery in response to air pressure changes during airplane flights. Approximately 46,437 units have been distributed worldwide.

The affected pumps may deliver an unexpected additional dose of insulin during aircraft takeoff, potentially causing severe hypoglycemia (low blood sugar) with resulting altered mental status, seizures, coma, or death. During landing, the pumps may deliver insufficient insulin, potentially causing severe hyperglycemia (high blood sugar), dehydration, and diabetic ketoacidosis.

The recalled models are MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, and MMT-751, which have been distributed across all 50 U.S. states and internationally. Patients currently using one of these pumps should contact their healthcare provider or Medtronic MiniMed for guidance regarding air travel and insulin management.

The recalled product

Product
Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
Manufacturer
Medtronic MiniMed, Inc.
Category
Medical Device — Insulin Delivery System
Hazard
Affected units
46,437

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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