InPen App, CFN: MMT-8060 (iOS Users) and MMT-8061 (Android Users)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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
FDA enforcement status: Ongoing
Brands named
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAMedtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965; Cardiopulmonary bypass vascular catheter2026-04-21
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