Insulin pump recall: Medtronic Paradigm models malfunction during airplane flight
Medtronic MiniMed's Paradigm insulin pumps can malfunction during airplane flight due to air pressure changes, potentially causing dangerously high or low blood sugar levels that could be fatal.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source explicitly states that the insulin delivery malfunction can result in death during both take-off and landing. Per the severity rubric, any source mentioning death warrants a Critical severity score regardless of agency classification.
Plain-English summary
Medtronic MiniMed, Inc. is recalling Paradigm series insulin pumps and related models (Minimed 530G, 6XX series, and 7XX series) affecting approximately 41,404 units distributed worldwide, including throughout the United States.
The pumps can malfunction during airplane flight due to changes in air pressure. During take-off, the pump may deliver an unexpected additional dose of insulin, potentially causing severe hypoglycemia (dangerously low blood sugar), altered mental status, seizures, coma, or death. During landing, the pump may deliver an insufficient dose, potentially causing severe hyperglycemia (dangerously high blood sugar), dehydration, diabetic ketoacidosis, or death.
This recall affects all users of the affected pump models.
The recalled product
- Product
- Paradigm insulin pump, REF: MMT-754
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Insulin Pump
- Hazard
- insulin-delivery-malfunction
- 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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