MiniMed Insulin Pump May Malfunction at High Altitude During Flight
Medtronic MiniMed insulin pumps may deliver abnormal insulin doses during airplane takeoff or landing due to air pressure changes, potentially causing severe low or high blood sugar.
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: This FDA Class II recall involves potential for life-threatening outcomes (death, seizure, coma) from abnormal insulin delivery triggered by altitude pressure changes. However, no illnesses, injuries, or deaths have been reported in the source text. Per the rubric, risk-of-harm products with no reported harm qualify as High (Score 3) rather than Severe.
Plain-English summary
Medtronic MiniMed insulin pumps (including 770G series and earlier Paradigm, 530G, 6XX, and 7XX series) are subject to recall due to potential abnormal insulin delivery caused by changes in air pressure. This malfunction can occur during airplane takeoff or landing.
An unexpected additional insulin dose during takeoff may cause severe hypoglycemia, which can lead to altered mental status, seizures, coma, or death. An unexpected under-delivery of insulin during landing may cause severe hyperglycemia, dehydration, or diabetic ketoacidosis, which can also be life-threatening.
Approximately 106,289 units have been distributed worldwide, including across all U.S. states and territories, as well as internationally.
Patients using affected pumps should contact Medtronic MiniMed for further guidance. Any patient experiencing symptoms of severe low or high blood sugar while flying should seek immediate medical attention.
The recalled product
- Product
- MiniMed insulin pump, REF: 770G (MMT-1880, MMT-1881, MMT-1882, MMT-1890, MMT-1891, MMT-1892)
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Insulin Pump
- Hazard
- insulin-malfunction
- altitude-sensitivity
- severe-hypoglycemia
- severe-hyperglycemia
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.
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