MiniMed Go App Recalled Due to Missed Insulin Alerts
Medtronic is recalling its MiniMed Go app because a software bug can prevent insulin dose alerts during nighttime, potentially leading to missed doses and hyperglycemia.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall involving a risk-of-harm software defect that could lead to missed insulin doses and hyperglycemia, though no injuries have been reported.
Plain-English summary
The U.S. Food and Drug Administration has authorized Medtronic MiniMed, Inc. to recall approximately 3,465 MiniMed Go app units worldwide. The recall affects Model MMT-8600 (iOS) and MMT-8601 (Android) with software versions 1.0.0 and 1.1.0.
The defect occurs when users turn off the 'Set day and night' feature while enabling 'missed dose' or 'Correct high glucose' alerts. Under these conditions, nighttime alerts will not trigger, which could result in missed rapid-acting insulin doses without the user's knowledge.
This software issue may lead to delayed therapy and an increased risk of hyperglycemia in users who rely on the app for insulin management. No illnesses or injuries have been reported in connection with this issue.
Consumers should immediately update the app to the latest version or contact Medtronic for assistance. Users should monitor their glucose levels closely and follow their healthcare provider's instructions until the issue is resolved.
The recalled product
- Product
- MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
- Manufacturer
- Medtronic MiniMed, Inc.
- Hazard
- insulin-missed-dose
- hyperglycemia
- software-bug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- 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
Distribution
Distributed nationwide across the United States.
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