FDA-Device2026-04-01Class IIPROCESSING DEFECT

Medtronic MiniMed 780G insulin pump recalled for software defects causing inaccurate insulin delivery

OTHERNationwide distributionMedical devices

What this means

Medtronic has recalled certain MiniMed 780G insulin pumps due to software defects that can cause the pump to deliver too much insulin, too little insulin, or stop delivering insulin entirely. These defects appeared after software updates (versions 6.60, 6.61, and 6.62) and may result in dangerously high or low blood sugar levels. The recall affects over 26,000 pumps with specific serial numbers.

Check if your MiniMed 780G serial number matches the recall list (begins with NG2, NG3, etc.)
Contact Medtronic or your healthcare provider immediately if your pump is affected
Do not update your pump software to versions 6.60, 6.61, or 6.62
Continue monitoring your blood sugar closely and follow your doctor's guidance while resolving this issue

The agency's original wording

Hazard

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).

Intended for

Adults

Illnesses reported

None reported

Sold states

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.

Affected count

26,851 pumps

Manufactured in

18000 Devonshire St, Northridge, CA, United States

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1635-2026

More Medtronic recalls

FDA-Device2026-07-29
Medtronic MiniMed Go App recalled for missed insulin alerts at night

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