Medtronic MiniMed 630G and 670G insulin pumps sold in last 6 months may not deliver basal insulin without proper setup, risking severe hyperglycemia and diabetic ketoacidosis. Affected units have serial numbers from NG2056884H to NG2891033H (US) or NG1921788H to NG2883091 (OUS).
New or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.), which must be set up and saved on pumps prior to use. Patients who do not realize this will receive no basal insulin, which can lead to insulin under-delivery. Insulin under-delivery can cause severe hyperglycemia, which may lead to diabetic ketoacidosis. Current device labeling does not clearly identify that these insulin pumps are capable of functioning with the default basal setting of 0.0 units/hr for all 24 hours and that no error message will appear if the default basal setting remains active. Furthermore, the labeling for the affected devices does not highlight that saving the basal settings requires multiple steps and failure to complete all steps will not save the new basal settings, nor that the steps required to set and save a basal profile and other parameters which are used as part of the bolus calculator function are different.
Medtronic MiniMed 630G and 670G insulin pumps sold in the last six months may not deliver basal insulin if not properly programmed. This can cause severe hyperglycemia and diabetic ketoacidosis, a life-threatening condition for people with type 1 diabetes.
The pumps are pre-programmed with basal rates set to 0.0 units per hour, meaning they deliver no insulin. Patients must manually set up and save basal rates and other settings before use. Failure to complete all steps may result in no insulin delivery, causing severe hyperglycemia and potentially diabetic ketoacidosis.
People with type 1 diabetes who use these insulin pumps. Those who have not set up basal rates or verified settings on the pump are at highest risk.
Check if your pump has a serial number between NG2056884H and NG2891033H (US) or NG1921788H and NG2883091 (OUS). These pumps were sold in the last six months and are part of the MiniMed 630G or 670G systems.
Verify that basal rates have been set up and saved on the pump before use. If not, the pump may not deliver insulin.
Reach out to Medtronic MiniMed for guidance on setting up basal rates and verifying settings.
The pumps are pre-programmed with basal rates set to 0.0 units per hour, meaning they deliver no insulin. Patients must manually set up and save basal rates and other settings before use. Failure to complete all steps may result in no insulin delivery, causing severe hyperglycemia and potentially diabetic ketoacidosis.
Check if your pump has a serial number between NG2056884H and NG2891033H (US) or NG1921788H and NG2883091 (OUS). If you have one, contact Medtronic MiniMed for guidance on setting up basal rates and verifying settings.
The recall does not require returning the pump. Patients must set up basal rates and verified settings before use to ensure proper insulin delivery.
We’ve drafted a message you can send Medtronic MiniMed to request your refund or repair — edit it as you like.
Subject: Recall Z-0855-2022 — Medtronic MiniMed Medtronic MiniMed Hello, I own a Medtronic MiniMed that is covered by recall Z-0855-2022 from Medtronic MiniMed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
