Recall Weekly
Moderate riskFDA DeviceClass II

Medtronic MiniMed Go App recalled for missed insulin alerts at night

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.

From the FDA notice · Read the official notice ↗ · All Medtronic recalls

What to do

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

Is yours affected?

Compare your label or packaging with the recalled product.

Product
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Sold in
Nationwide
Made for
All ages (under 100 years)

Details

Units affected
3,465
Illnesses reported
None reported
Manufactured in
18000 Devonshire St, N/A, Northridge, CA, United States
Classification
Class II
Recall number
Z-2778-2026

In the FDA's words

Description
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) 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. 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 Distribution: 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 quantity: 3,465
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.

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