FDA-Device2026-07-29Class IIPROCESSING DEFECT

Medtronic MiniMed Go App recalled for missed insulin alerts at night

OTHERNationwide distribution

Medtronic MiniMed Go App recalled for missed nighttime alerts

Medtronic MiniMed Go app versions 1.0.0 and 1.1.0 have a software bug: when the "Set day and night" feature is turned off, missed-dose and high-glucose alerts may fail to trigger at night. This means users may not realize they've missed insulin doses, potentially delaying treatment and raising blood sugar levels dangerously.

Update to MiniMed Go app version 1.2.0 or later
Do not turn off the "Set day and night" feature if you use missed-dose or high-glucose alerts
Contact Medtronic or your healthcare provider if you have questions about your device

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.

Sold states

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.

Affected count

3,465

Manufactured in

18000 Devonshire St, N/A, Northridge, CA, United States

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2778-2026

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