FDA-Device2025-12-24Class IIPROCESSING DEFECT

Medtronic MiniMed InPen App Android recall for missing notification settings

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What this means

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.

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

The agency's original wording

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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 count

8251

Manufactured in

18000 Devonshire St, Northridge, CA, United States

Products

InPen App, Model/CFN Number: MMT-8061 (Android Users)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0958-2026

More Medtronic recalls

FDA-Device2026-07-29
Medtronic MiniMed Go App recalled for missed insulin alerts at night

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