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Medtronic MiniMed, Inc.: MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)

Medical DevicesSource: FDA (device) · Date: 2026-07-29

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medtronic MiniMed, Inc.
Product
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Reason / hazard
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide - US Nationwide distribution in the states and territories of PR, OH, WA, IL, NC, PA, VA, MN, ID, CA, UT, MI, NJ, MS, SC, CO, AZ, OR, AR, MO, TX, AL, FL, NY, IN, TN, IA, WI, MA, LA, OK, GA, KS, NM, CT, KY, NH, NV, MD and the countries of Australia, Switzerland, Germany, Denmark, Spain, Finland, Iceland, Norway, Sweden.
Recall initiated
2026-06-16
Code info
Model/UDI-DI: MMT-8600/00199150038978(10)1.1.0, MMT-8601/00199150038985(10)1.1.0 Software Versions: 1.0.0, 1.1.0
Product quantity
3,465
Voluntary mandated
Voluntary: Firm initiated
City
Northridge
State
CA
Country
United States
Event id
99228
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