Medtronic MiniMed, Inc. recalls InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)

Recall date

June 16, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2496-2025

FDA classification

Class II

Brand / firm

Medtronic MiniMed, Inc.

Sold / distributed

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, Portuga…

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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