Official recall record
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-06-16
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Medtronic MiniMed, Inc.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2026-08-20 · US FDA — Medical Devices
Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Pro - 2026-07-13 · US FDA — Medical Devices
MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712; - 2026-07-13 · US FDA — Medical Devices
MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
All 30 official recall notices naming Medtronic MiniMed, Inc. on this site →