Recall Z-0251-2020— Senseonics, Inc.
Class II · Terminated
Class II FDA medical device recall by Senseonics, Inc., initiated 2019-09-18, terminated 2020-07-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor. Reason: Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface.
- Recalling firm
- Senseonics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-09-18
- Terminated
- 2020-07-30
- Firm location
- Germantown, MD, United States
Product description
Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
Reason for recall
Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface
Data sourced from openFDA. This site is unofficial and independent of the FDA.