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InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android… recallZ-2496-2025 · Medtronic MiniMed, Inc. · initiated Jun 16, 2025

Class II Open, Classified All recalls posted in September 2025

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic MiniMed, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-2496-2025
Recall class
Class II
Status
Open, Classified
Initiated by the company
Jun 16, 2025
Posted by the FDA
Sep 2, 2025
Recalling firm
Medtronic MiniMed, Inc.
Quantity
6816
Product code
NDC
FDA submissions
K242775
Distribution
International distribution to the countries of Argentina, Australia, Austria, Belgium, Bermuda, Chile, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Luxembourg, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

Product description

InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)

Code information (models, lots, serial numbers)

UDI-DI: 0763000B000122075 CFN/Software Version: MMT-8060/7.0.0, 7.1.0, 7.2.0 and 7.5.0 MMT-8061/7.0.0, 7.0.1, 7.1.0, 7.1.1, 7.2.0 and 7.5.0

Other devices under the same FDA submission

1 device cleared under K242775 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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