Eversense CGM Sensors Recalled for Premature Function Failure
Senseonics is recalling 1,344 Eversense CGM sensors nationwide because they may stop working early due to inadequate hydration of the glucose-sensing surface.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II. The hazard involves a medical device failing to provide critical glucose monitoring data, which poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Senseonics, Inc. is recalling 1,344 Eversense CGM Sensors (FG-4200-00-301) distributed nationwide. The recall was initiated because the sensors have prematurely stopped functioning due to inadequate hydration of the sensor's glucose-sensing surface.
The affected sensors are identified by specific serial numbers listed in the official recall documentation. This issue affects patients using the Eversense continuous glucose monitoring system who may experience a loss of glucose data if their sensor is part of this recall.
Consumers should check their sensor serial numbers against the list provided by the FDA or Senseonics. If a sensor is affected, users should contact Senseonics for instructions on replacement or further guidance.
The recalled product
- Product
- Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
- Manufacturer
- Senseonics, Inc.
- Affected units
- 1,344
Distribution
Distributed nationwide across the United States.
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