InPen App, Model/CFN Number: MMT-8061 (Android Users) (Medtronic MiniMed, Inc.) – when app is uninstalled and reinstall... (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
InPen App, Model/CFN Number: MMT-8061 (Android Users)
Brand
Medtronic MiniMed, Inc.
Lot Codes / Batch Numbers
Software Versions: 7.5.0, 7.5.1, and 8.0.0. UDI-DI: 00763000974596
Products Sold
Software Versions: 7.5.0, 7.5.1, and 8.0.0. UDI-DI: 00763000974596
Medtronic MiniMed, Inc. is recalling InPen App, Model/CFN Number: MMT-8061 (Android Users) due to When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't ch. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY
Page updated: Jan 10, 2026
Important Notice
This page displays information sourced from the U.S. Food and Drug Administration (FDA). IsMyProductRecalled.com aggregates public data for convenience and does not issue recalls. We are not affiliated with any government agency. Always verify recall information with the official source before taking action. This is not medical or legal advice.