Recall Z-1259-2025— Medtronic MiniMed, Inc.
Class II · Ongoing
Class II FDA medical device recall by Medtronic MiniMed, Inc., initiated 2025-01-31. FDA's recall record names no specific 510(k) clearance for this event. Product: MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755). Reason: All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death..
- Recalling firm
- Medtronic MiniMed, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-31
- Firm location
- Northridge, CA, United States
Product description
MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
Reason for recall
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Data sourced from openFDA. This site is unofficial and independent of the FDA.