Company: Medtronic MiniMed, Inc
Date of Enforcement Report: 3/24/2026
Class: II

PRODUCT:

MiniMed” 780G – MMT-1884 MiniMed” 780G – MMT-1886 With Software 6.60 and 6.61

Recall Number:

Z-1635-2026

REASON:

Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).

RECALLING FIRM/MANUFACTURER:

Medtronic MiniMed, Inc

VOLUME:

26,851 pumps

DISTRIBUTION:

Worldwide – U.S. 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of Israel