MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;
FDA Recall Z-2980-2026 · Posted 2026-08-18
Advertisement
Recalling FirmMedtronic MiniMed, Inc.
Recall StatusOpen, Classified
Product CodeQFG
Date Initiated2026-07-13
Product Quantity16
Reason for Recall
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.
Firm 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
Root Cause
Process design
Distribution Pattern
International distribution to the countries of Germany, Denmark, Austria, Netherlands, United Kingdom, Italy, Belgium, Ireland, Switzerland, Sweden, Northern Ireland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement