Medtronic Paradigm insulin pump recall for abnormal delivery during flight
Medtronic MiniMed Paradigm insulin pumps may deliver incorrect insulin doses during airplane takeoff or landing due to air pressure changes. This can cause severe high or low blood sugar requiring immediate medical attention.
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 recall involves a life-critical device with potential for serious complications including seizures, coma, and death. Although no injuries have been reported, the serious nature of potential harms during high-risk situations justifies a High classification per the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic MiniMed is recalling Paradigm series insulin pumps due to a defect that causes abnormal insulin delivery in response to air pressure changes during airplane flights. Approximately 46,437 units have been distributed worldwide.
The affected pumps may deliver an unexpected additional dose of insulin during aircraft takeoff, potentially causing severe hypoglycemia (low blood sugar) with resulting altered mental status, seizures, coma, or death. During landing, the pumps may deliver insufficient insulin, potentially causing severe hyperglycemia (high blood sugar), dehydration, and diabetic ketoacidosis.
The recalled models are MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, and MMT-751, which have been distributed across all 50 U.S. states and internationally. Patients currently using one of these pumps should contact their healthcare provider or Medtronic MiniMed for guidance regarding air travel and insulin management.
The recalled product
- Product
- Paradigm insulin pump, REF: MMT-522, MMT-523, MMT-551, MMT-722, MMT-723, MMT-751
- Manufacturer
- Medtronic MiniMed, Inc.
- Hazard
- air-pressure-malfunction
- abnormal-insulin-delivery
- 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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