Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Paradigm REF: MMT-712 and MMT-715 Recalled by Medtronic MiniMed, Inc. Due to All Medtronic MiniMed pumps (Paradigm series, Minimed 530G,...

Date: January 31, 2025
Company: Medtronic MiniMed, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic MiniMed, Inc. directly.

Affected Products

Paradigm REF: MMT-712 and MMT-715

Quantity: 20,760 units

Why Was This Recalled?

All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. During a delivery accuracy dry run testing of the 780G NGP infusion pump under dynamic pressure conditions, the firm observed that when air pressure decreased during take-off simulation, on average 0.569U more insulin was delivered in 15 minutes than the expected delivery volume at ambient pressure at 1 U/hr delivery rate; when air pressure increased during landing simulation, on average 0.537 U less insulin was delivered in 25 minutes than the expected delivery volume at ambient pressure at 1 U/hr delivery rate. The firm also observed that the mechanisms causing the variations in delivery volumes are independent of the delivery rate.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Medtronic MiniMed, Inc.

Medtronic MiniMed, Inc. has 22 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report