Medtronic MiniMed, Inc. recalls InPen App

Medtronic MiniMed, Inc. is recalling InPen App for iOS and Android users due to software design errors that could lead to a missed short-acting insulin dose reminder and a recommendation to correct a high glucose value. It does not impact insulin delivery, long-acting insulin dose reminders, or CGM alerts, and users can still use the pen itself to calculate a dose, deliver insulin, record the dose date/time, and view CGM data. This issue was identified during internal testing before release in the US but after release to OUS customers, no complaints or MDRs related to this recall have been reported. Use of the affected device may result hyperglycemia by failing to alert the user and delay treatment of diabetes.

On 6/16/2025, correction notices were emailed to customers who were asked to do the following: Actions Required: Users of InPen app software should update to version 7.5.1 or higher. For iOS Users - 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. - Open the App Store. - Tap your profile icon at the top of the screen. - Scroll to see pending updates. - Tap Update next to the InPen app icon. For Android Users - 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. - 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. Firm's 24-Hr Technical Support: 1-800-646-4633

• FDA enforcement recordOfficial FDA database entry for Z-2496-2025
• FDA 510(k) clearance · K242775The device's official FDA premarket clearance record
• FDA device classification · NDCOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.1890The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Medtronic MiniMed, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.