Medtronic MiniMed insulin pump recalled for abnormal delivery during air pressure changes
Medtronic MiniMed insulin pumps may deliver insulin abnormally during airplane take-off or landing due to air pressure changes, risking severe low or high blood sugar emergencies.
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 medical device recall involves serious potential consequences including death, seizures, and hyperglycemic emergencies, but no injuries or illnesses have been reported to date. It qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medtronic MiniMed is recalling approximately 4,959 insulin pump units (MiniMed 700G and other series). The pumps may deliver insulin incorrectly when exposed to air pressure changes that occur during airplane take-off and landing.
During take-off, the pump may deliver an unexpected additional dose of insulin, potentially causing severe low blood sugar (hypoglycemia) with serious complications including altered mental status, seizures, coma, and death.
During landing, the pump may under-deliver insulin, potentially causing dangerously high blood sugar (hyperglycemia) that can lead to dehydration, diabetic ketoacidosis, and death.
These pumps have been distributed worldwide, including throughout all U.S. states and numerous countries. The recall affects all lot numbers and UDI numbers of the affected pump models.
The recalled product
- Product
- MiniMed insulin pump, REF: 700G (MMT-1801, MMT-1805, MMT-1850, MMT-1851)
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Insulin Pump
- Hazard
- insulin-delivery-malfunction
- hypoglycemia-risk
- hyperglycemia-risk
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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