InPen App, Model/CFN Number: MMT-8061 (Android Users)
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | November 13, 2025 |
| Reported | December 24, 2025 |
| Recalling firm | Medtronic MiniMed, Inc. |
| Country / region | United States CA |
Hazard
When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on mute/Do Not Disturb, and previously set up override permission is deleted, so audible and vibratory notifications not received, which may lead to delayed insulin therapy, hyperglycemia.
Affected products
- InPen App, Model/CFN Number: MMT-8061 (Android Users)
Related recalls
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