Official recall record

Paradigm REF: MMT-712 and MMT-715

US FDA — Medical Devices · 2025-01-31 · United StatesClass II

Issuing authority: US FDA — Medical Devices
Recall initiated by firm: 2025-01-31
Country of alert: United States
Alert level: Class II
Alert type: recall
Brand on record: Medtronic MiniMed, Inc.

What the authority reported

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.

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

More recalls: US FDA — Medical Devices · United States · all filters

Other recalls from this brand

2026-08-20 · US FDA — Medical Devices
Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Pro
2026-07-13 · US FDA — Medical Devices
MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;
2026-07-13 · US FDA — Medical Devices
MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;

All 30 official recall notices naming Medtronic MiniMed, Inc. on this site →

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