Germantown, MD, United States
Senseonics, Inc. recalls
1 recall recorded since 2018, most recently on 18 September 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 18 September 2019
- Terminated
- 30 July 2020
- Reason
- Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0251-2020
- Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.