Medtronic MiniMed, Inc.: InPen App, Model/CFN Number: MMT-8061 (Android Users)
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- Company / brand
- Medtronic MiniMed, Inc.
- Product
- InPen App, Model/CFN Number: MMT-8061 (Android Users)
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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
- Recall initiated
- 2025-11-13
- Code info
- Software Versions: 7.5.0, 7.5.1, and 8.0.0. UDI-DI: 00763000974596
- Product quantity
- 8251
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northridge
- State
- CA
- Country
- United States
- Event id
- 97904
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