Medtronic MiniMed, Inc. — 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.
Is this relevant to me?
- Geography
- 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
- Source agency
- FDA
- Category
- Health
- Published
- November 13, 2025
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
What's affected?
- Product
- InPen App, Model/CFN Number: MMT-8061 (Android Users)
- Lot code
- Software Versions: 7.5.0, 7.5.1, and 8.0.0. UDI-DI: 00763000974596
Additional details
Software Versions: 7.5.0, 7.5.1, and 8.0.0. UDI-DI: 00763000974596
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 8251.
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