Recall Weekly
Moderate riskFDA DeviceClass II

Medtronic MiniMed InPen app recalled for notification failure risk

Medtronic MiniMed InPen App users on Android (versions 7.5.0, 7.5.1, and 8.0.0) may lose insulin reminders if they uninstall and reinstall the app. The notification settings screen doesn't appear during setup, preventing notifications from overriding your phone's mute or Do Not Disturb mode. This could delay insulin therapy.

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

What to do

  1. Do not uninstall the InPen App unless you update to the latest version first
  2. Check your notification settings in the app to ensure alerts can override your phone's mute setting
  3. Visit the Medtronic support website for the latest InPen App update
  4. Monitor your blood sugar closely and set phone reminders as a backup
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
InPen App, Model/CFN Number: MMT-8061 (Android Users)
Sold in
Nationwide
Made for
Adults (18 years to 100 years)

Details

Units affected
8251
Illnesses reported
None reported
Manufactured in
18000 Devonshire St, Northridge, CA, United States
Classification
Class II
Recall number
Z-0958-2026

In the FDA's words

Description
InPen App, Model/CFN Number: MMT-8061 (Android Users) When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia. Software Versions: 7.5.0, 7.5.1, and 8.0.0. UDI-DI: 00763000974596 Distribution: US: IL, AZ, MN, NE, KS, TN, CA, FL, TX, WA, MO, NC, NY, WI, IN, ME, CT, RI, MD, PA, OK, KY, MA, DE, UT, ID, VA, MI, OH, LA, NJ, IA, MT, HI, AR, OR, SC, AL, CO, WY, VT, NV, GA, MS, SD, AK, WV, NH, ND, NM. OUS: Austria, Belgium, Chile, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, South Africa, Spain, Sweden, Switzerland, United Kingdom Affected quantity: 8251
Hazard
When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia.

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