Recall Z-2980-2026 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
Medtronic MiniMed, Inc.
MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;
| Date | Aug 18, 2026 (initiated Jul 13, 2026) |
| Status | Open, Classified |
| Reason | Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis. |
| Root cause | Process design |
| Action | On 7/13/2026, field safety notices were sent to customers asking them to do the following: 1) Stop using the loaner pump and contact the firm to arrange for loaner pump return. 2) Contact your Healthcare Professional (HCP) to ensure you have access to backup insulin therapy supplies or alternative plans, which may include short- and long-acting insulins, syringes, with dosage instructions from your HCP. 3) Complete and return the customer acknowledgement form. Questions can be directed to the firm's Tech Support: 1-800-646-4633 |
| Quantity | 16 |
| Distribution | International distribution to the countries of Germany, Denmark, Austria, Netherlands, United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, Northern Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K251032 | MiniMed 780G insulin pump Medtronic Minimed, Inc., Jul 1, 2025 |