Medtronic MiniMed recalls InPen App for iOS and Android users with software versions 7.0.0-7.5.0 due to missed insulin dose reminders. This could lead to hyperglycemia if users don't receive alerts for high glucose levels. The device itself still works for insulin delivery and CGM data.
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.
Medtronic MiniMed is recalling its InPen App for iOS and Android users with specific software versions because software errors might cause missed insulin dose reminders. This could lead to high blood sugar levels if users don't get alerts for high glucose values, but the device still functions for insulin delivery and glucose monitoring.
The software has design errors that can cause the app to fail to alert users about missed short-acting insulin doses or high glucose levels. This might delay treatment of diabetes, leading to hyperglycemia. However, the device still works for insulin delivery and glucose monitoring.
People using Medtronic MiniMed's InPen App with iOS or Android devices and the affected software versions are at risk. Those with diabetes who rely on the app for dose reminders are most vulnerable.
Check your InPen App version: iOS users with MMT-8060 software versions 7.0.0, 7.1.0, 7.2.0, or 7.5.0; Android users with MMT-8061 software versions 7.0.0, 7.0.1, 7.1.0, 7.1.1, 7.2.0, or 7.5.0. The recall was issued for devices sold in the US after internal testing.
Review your InPen App version to see if it matches the affected software versions listed in the recall.
Update to a newer version of the app to fix the software errors that could cause missed reminders.
No, the recall only affects the app's reminders for insulin doses and glucose levels. The device still delivers insulin and records doses.
iOS users with MMT-8060 software versions 7.0.0, 7.1.0, 7.2.0, and 7.5.0; Android users with MMT-8061 software versions 7.0.0, 7.0.1, 7.1.0, 7.1.1, 7.2.0, and 7.5.0.
The recall states that use of the affected device may result in hyperglycemia, but it does not mention serious injury risks. The device itself still functions for insulin delivery.
We’ve drafted a message you can send Medtronic MiniMed to request your refund or repair — edit it as you like.
Subject: Recall Z-2496-2025 — Medtronic MiniMed Medtronic MiniMed Hello, I own a Medtronic MiniMed that is covered by recall Z-2496-2025 from Medtronic MiniMed. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
