Medtronic Paradigm insulin pumps may deliver incorrect doses during flight
Medtronic MiniMed insulin pumps may deliver abnormally high or low insulin doses in response to air pressure changes during airplane takeoff and landing, potentially causing severe hypoglycemia or hyperglycemia.
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 an FDA Class II recall affecting a risk-of-harm medical device where insulin delivery errors could result in severe hypoglycemia or hyperglycemia with potential for death. However, no injuries or hospitalizations have been reported to date, and the hazard was identified through testing rather than field incidents.
Plain-English summary
Medtronic MiniMed is recalling all of its insulin pump models, including Paradigm series, Minimed 530G, and 6XX and 7XX series pumps, because air pressure changes during airplane takeoff and landing can cause the pumps to deliver incorrect amounts of insulin.
During testing under simulated flight conditions, the manufacturer observed that when air pressure decreases during takeoff, pumps deliver 0.569 additional units of insulin over 15 minutes beyond the expected dose. When air pressure increases during landing, pumps deliver 0.537 fewer units of insulin over 25 minutes than expected. These delivery variations occur independent of the rate being prescribed.
An unexpected overdose of insulin can cause severe hypoglycemia (low blood sugar), leading to altered mental status, seizures, coma, or death. An unexpected underdose can cause severe hyperglycemia (high blood sugar), dehydration, and diabetic ketoacidosis, potentially leading to death. The recall affects 20,760 units distributed worldwide.
The recalled product
- Product
- Paradigm REF: MMT-712 and MMT-715
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Insulin Pump
- Hazard
- insulin-overdose
- insulin-underdose
- hypoglycemia
- 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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