MiniMed Insulin Pump Models Recalled for Abnormal Delivery During Flight
Medtronic is recalling MiniMed insulin pumps due to air pressure changes during airplane takeoff and landing that can cause abnormal insulin delivery. Overdoses risk severe hypoglycemia; underdoses risk severe hyperglycemia and diabetic ketoacidosis.
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 is a Class II recall for a life-critical medical device with potential for serious harm including seizures, coma, and death, but no actual illnesses or hospitalizations have been reported, fitting the rubric criterion for high-severity risk-of-harm products without reported injury.
Plain-English summary
Medtronic MiniMed, Inc. is recalling MiniMed insulin pumps (Paradigm series, 530G, 6XX series, and 7XX series) due to abnormal insulin delivery triggered by air pressure changes during airplane takeoff and landing.
The affected pumps total approximately 15,439 units and have been distributed worldwide across all US states and numerous countries. During takeoff, affected pumps may deliver an unexpected additional dose of insulin, which can result in severe hypoglycemia, altered mental status, seizures, coma, or death. During landing, affected pumps may deliver less insulin than expected, which can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
The recalled product
- Product
- MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Insulin pump
- Hazard
- hypoglycemia
- hyperglycemia
- device-malfunction
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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