Medtronic MiniMed insulin pump recalled for air pressure-triggered delivery defect
Medtronic MiniMed insulin pumps can deliver abnormal insulin doses during air pressure changes in airplane travel, risking severe hypoglycemia or hyperglycemia and serious complications.
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: FDA Class II recall for a documented defect in a medical device that poses serious health risks including potential seizures, coma, and death. No actual illnesses or injuries are explicitly reported in the source material, placing this in the 'risk-of-harm' category rather than confirmed-incident category.
Plain-English summary
Medtronic MiniMed insulin pumps (including the 670G series) are being recalled worldwide. The recall affects approximately 100,074 units distributed across the United States and numerous countries globally.
These pumps can malfunction in response to air pressure changes experienced during airplane takeoff and landing. During takeoff, when cabin pressure decreases, the pump may deliver an unexpected additional insulin dose, potentially causing severe hypoglycemia, altered mental status, seizures, coma, or death. During landing, when cabin pressure increases, the pump may deliver insufficient insulin, potentially causing severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
The FDA has classified this as a Class II recall.
The recalled product
- Product
- MiniMed insulin pump, REF: 670G (MMT-1760, MMT-1761, MMT-1762, MMT-1780, MMT-1781, MMT-1782)
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Insulin pump
- Hazard
- abnormal-insulin-delivery
- severe-hypoglycemia
- severe-hyperglycemia
- seizure
- coma
- altered-mental-status
- diabetic-ketoacidosis
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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