PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: September 10, 2025 Initiated: June 16, 2025 #Z-2496-2025

Product Description

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

Reason for Recall

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.

Details

Recalling Firm
Medtronic MiniMed, Inc.
Units Affected
6816
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.
Location
Northridge, CA

Frequently Asked Questions

What product was recalled? ▼
InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users). Recalled by Medtronic MiniMed, Inc.. Units affected: 6816.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 10, 2025. Severity: Moderate. Recall number: Z-2496-2025.

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