FDA DeviceClass IINotable

FDA Recall: MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)

Date: 2026-07-29
Brand: Medtronic MiniMed, Inc.
Category: Medical Device
FDA Class: Class II

Description

For MiniMed Go app version 1.0.0 and 1.1.0, when the 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. 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.

Hazard

For MiniMed Go app version 1.0.0 and 1.1.0, when the 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. 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.

Remedy

3,465

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