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Terminated

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

FDA Recall Z-0251-2020 · Posted None

Recalling FirmSenseonics, Inc.
Recall StatusTerminated
Product CodeQHJ
Date Initiated2019-09-18
Date Terminated2020-07-30
Product Quantity1,344 Sensors

Reason for Recall

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

Firm Action

Senseonics issued Urgent Medical Device recall letter to HCPs and Distributors as two separate pdf documents) issued on Sep 18 as UPS next day (by noon) delivery. Letter states reason for recall, health risk and action to take: If you have inserted one of these sensors, there is no reason to remove it from the patient and replace it unless it prematurely stops functioning. Replacement Alert on the Eversense app. However, if any of these sensors are in inventory awaiting insertion at your office, DO NOT INSERT THESE SENSORS. Please immediately check your inventory for the identified serial numbers and quarantine affected stock on hand. We will replace affected sensors in your inventory. Please immediately complete the attached stamped and addressed response card and check your product status. Contact your Eversense sales representative or Customer Care at 1-844 SENSE4U (844-736-7348) 24 hours/7 days-a-week if you have any questions.

Root Cause

Process control

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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