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FDA recall, , Moderate risk

Medtronic MiniMed 780G Insulin Pumps

The MiniMed 780G insulin pump with software versions 6.60 and 6.61 has software defects that could cause hypoglycemia or hyperglycemia.

What happened

Medtronic MiniMed, Inc., of Northridge, California, recalled 26,851 MiniMed 780G insulin pumps with software versions 6.60 and 6.61, as well as versions 6.62, due to three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that could result in a risk of hypoglycemia or hyperglycemia from inaccuracies in insulin delivery, including under-delivery, over-delivery, or cessation of delivery.

The recall began January 30, 2026, and was added to the FDA's Enforcement Report on March 24, 2026.

The recalled pumps were distributed nationwide in the United States and in Israel. The defects occurred as a result of software updates to versions 6.60, 6.61, and 6.62.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Affected if its UDI-DI is listed.

A UDI-DI is the device identifier printed with the barcode on the device label.

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

    UDI-DI
    • 763000414344
    • 763000439859
    • 763000545604
    • 763000640095
    • 763000758547
    • 76300075854701
    • 763000865665
    • 76300086566501
    • 763000924089
    • 763000924102
    • 763000924119
    • 76300096001801
    • 76300096002501
    • 76300096004901
    • 763000384272
    • 76300096003201
    • 763000819392
    • 199150003686
    • 763000439866
    • 763000578640
    • 76300057864002
    • 763000586195
    • 76300058619502
    • 763000819378
    • 76300081937801
    • 763000819385
    • 76300081938501

Recall details

Company began the recall
Sold in

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.

Company
Medtronic MiniMed, Inc.Northridge, California
Risk

Moderate risk

Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.

FDA Class II recall · How risk is rated

Event ID
98444
Recall number
Z-1635-2026
Quantity recalled
26,851 pumps

All recalls from Medtronic MiniMed, Inc.

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. In FDA's weekly enforcement report

  4. Listed on Recall Canary

  5. Summary updated

Summary by Recall Canary, written with AI · summary updated Oct 3, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)