Medical device recalls Moderate risk

Senseonics, Inc. recalls Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

Recall date
September 18, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0251-2020
FDA classification
Class II
Brand / firm
Senseonics, Inc.
Sold / distributed
Nationwide

Why it was recalled

Eversense Sensors have prematurely stopped functioning due to inadequate hydration of the sensor s glucose-sensing surface

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor

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