The FDA announced on Jan. 27, 2022, that Medtronic MiniMed is recalling specific MiniMed insulin pumps due to a hazard of severe hyperglycemia and diabetic ketoacidosis. The devices may not be pre-programmed with basal rates or other verified settings required for proper function.
How to tell if you have it
- MiniMed 630G: MMT-1715, MMT-1754, MMT-1755
- MiniMed 670G: MMT-1740, MMT-1741, MMT-1742, MMT-1760, MMT-1761, MMT-1762
- Serial numbers NG2056884H to NG2891033H (US) and NG1921788H to NG2883091 (OUS)
The hazard
According to the FDA, new or replacement insulin pumps are not pre-programmed with basal rates or other verified settings that must be set up and saved 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.
Context
GovInfoNow's records show Medtronic MiniMed has had 5 other recalls on record since June 27, 2019. Other recent recalls of similar products include Medtronic Guardian App Recalls: Data Not Uploading Risk (Nov. 21, 2022), Medtronic MiniMed 600 Series Insulin Pumps: Cybersecurity Vulnerability Risk (Sept. 20, 2022), and Medtronic MiniMed - Insulin Pumps (May 23, 2022).