Insulin Pump Recalled for Abnormal Delivery During Flight Pressure Changes
Medtronic MiniMed 720G insulin pumps may malfunction during airplane travel due to air pressure changes, causing abnormal insulin doses that can lead to severe low or high blood sugar emergencies.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is a Class II FDA recall of a critical medical device (insulin pump) with potential for serious medical emergencies including death, seizures, coma, and diabetic ketoacidosis, meeting the Severe severity criterion for a high-risk device defect.
Plain-English summary
Medtronic MiniMed is recalling the MiniMed 720G insulin pump (model numbers MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867) for a safety defect affecting insulin delivery during air travel. Approximately 8,677 units have been distributed worldwide, including throughout all US states and numerous countries.
The pumps can malfunction in response to air pressure changes that occur during airplane takeoff and landing. An unexpected additional insulin dose during takeoff can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected reduction in insulin delivery during landing can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Patients using this pump, particularly those who travel by air, should be aware of these potential risks.
The recalled product
- Product
- MiniMed insulin pump, REF: 720G (MMT-1809, MMT-1810, MMT-1859, MMT-1860, MMT-1867)
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Insulin Pump
- Hazard
- insulin-delivery-malfunction
- hypoglycemia
- hyperglycemia
- air-pressure-sensitivity
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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