InPen App, Model/CFN Number: MMT-8061 (Android Users)
- Company
- Medtronic Minimed Inc.
- Recall Initiated
- November 13, 2025
- Posted
- December 18, 2025
- Recall Number
- Z-0958-2026
- Quantity
- 8251
- Firm Location
- Northridge, CA
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.
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
Lot / Code Info
Software Versions: 7.5.0, 7.5.1, and 8.0.0. UDI-DI: 00763000974596
Root Cause
Software Design Change
Action Taken
On 11/13/2025, correction notices were emailed to customers who were asked to update to version 8.0.1 or higher as soon as possible to resolve this issue. 1.Verify your app version: -On the home screen, navigate to the Settings menu (lower right corner). - Select Help and Support. - Note the App Version displayed. 2. If you are running versions 8.0.0, update to the latest version 8.0.1 or higher via the Google Play Store: - Open the Google Play Store. - Tap your profile icon at the top of the screen, then select Manage apps & device. - Tap Updates available or search for the InPen app. - Tap Update next to the InPen app icon. Electronically acknowledge that you have read and understand this notification and have followed the actions listed For questions, contact the firm's 24-Hour Technical Support line at 1-800-646-4633, option #1. The Customer Confirmation Form can also be emailed to the firm at rs.safetyinformation@medtronic.com