WhichRecall
Class IIReported 2025-12-24

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

Recalled by Medtronic MiniMed, Inc.

Reason for Recall

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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Recall Number
Z-0958-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-11-13
Reported
2025-12-24
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
Code Info
Software Versions: 7.5.0, 7.5.1, and 8.0.0. UDI-DI: 00763000974596
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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