MiniMed Insulin Pumps Recalled for Abnormal Insulin Delivery During Flight
MiniMed insulin pumps may deliver abnormal insulin doses during aircraft takeoff and landing due to air pressure changes, risking severe blood sugar fluctuations, seizures, and potentially fatal complications.
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: FDA Class II recall of a critical insulin delivery device with potential for severe, life-threatening outcomes including death, seizures, and diabetic ketoacidosis. No actual illnesses or deaths are documented in the source text.
Plain-English summary
Medtronic MiniMed is recalling MiniMed insulin pumps of the 630G series and related models. Approximately 70,587 units have been distributed worldwide, including throughout the United States and international markets.
The pumps contain a defect in insulin delivery related to air pressure changes that occur during aircraft takeoff and landing. During takeoff, the device may deliver an unexpected additional dose of insulin. During landing, the device may deliver less insulin than intended.
An unexpected additional dose can result in severe hypoglycemia, altered mental status, seizures, coma, or death. An unexpected under-delivery can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. Users of these pumps should be particularly cautious during air travel.
The recalled product
- Product
- MiniMed insulin pump, REF: 630G (MMT-1714, MMT-1715, MMT-1754, MMT-1755)
- Manufacturer
- Medtronic MiniMed, Inc.
- Category
- Medical Device — Insulin Pump
- Hazard
- abnormal-insulin-delivery
- hypoglycemia
- hyperglycemia
- diabetic-ketoacidosis
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.
Related recalls
Same category
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27