Recall Z-1264-2025 ยท OYC Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor
Medtronic MiniMed, Inc.
MiniMed insulin pump, REF: 740G (MMT-1811, MMT-1812, MMT-1861, MMT-1862)
| Date | Mar 3, 2025 (initiated Jan 31, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | On January 31, 2025, Medtronic MiniMed issued a "Urgent Medical Device Correction" notification to all affected consignees. The notification was distributed via: e-mail, certified mail, SMS text message or phone call. 1. Monitor Your Glucose Levels: 2. Discuss how to prepare for situations like this with your healthcare professional. 3. Respond to Alerts and Symptoms. 4. Please acknowledge that you have read and understood this notification and have followed the actions listed in this letter by either completing and returning the confirmation form, scanning the QR code below with your p |
| Quantity | 15,439 units |
| Distribution | Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY and the countries of |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.