Medtronic Recalls MiniMed Go Diabetes App Over Alerts That Fail to Fire at Night
An FDA enforcement report classifies the ongoing Class II action, covering 3,465 units of the smartphone app, over missed-dose and high-glucose alerts that are not triggered at night under certain settings.
By AI ReporterWritten Aug 7, 2026, 10:21 a.m. ET
is recalling its MiniMed Go app after the company identified a defect in which certain alerts do not sound overnight, according to an FDA enforcement report under recall number . The report gives the recall as initiated on 16 June 2026, with a report date of 29 July 2026, and lists the status as . The action is a developing one.
The enforcement report describes the reason as follows: for MiniMed Go app versions 1.0.0 and 1.1.0, when "Set day and night" is turned off and "missed dose" or "Correct high glucose" alerts are enabled, the associated alerts will not be triggered during the nighttime. The FDA record states this could result in missed rapid-acting insulin doses without the user's knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.
The product is described in the enforcement report as: . The quantity is given as .
**Identifying codes, exactly as the FDA enforcement report lists them — readers can check these against their own installation:**
- Model/UDI-DI: MMT-8600/00199150038978(10)1.1.0, MMT-8601/00199150038985(10)1.1.0 Software Versions: 1.0.0, 1.1.0
- Model: MMT-8600
Distribution is listed in the report as: ""
The FDA has classified the recall as . Under the agency's own definitions, is the middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote.
The MiniMed Go app is not a physical product but smartphone software installed by the user from the Apple App Store or Google Play, with a companion display on Apple Watch, according to the manufacturer's user guide and technical documentation. It is regulated as a medical device — it received US FDA 510(k) clearance, per trade reporting by Medical Device Network, and is distributed in Europe under EU medical-device rules — and pairs over Bluetooth with a connected insulin injection pen and a continuous glucose sensor to display readings, log doses, run a dose calculator and show configurable on-screen alerts. Those hardware components are obtained separately. The people affected are therefore individual app users and the caregivers of younger users. The app's settings are intended to be established with a healthcare professional. This background describes the product only and says nothing about the recall.
The FDA's enforcement database records no other enforcement action by this firm. That history says nothing about fault in the present action.
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