Guardian 4 Glucose Sensor, REF: MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, MMT-7040MA, MMT-7040QC1, MMT-7040QC2, MMT-7040QC3

Some sensors may have a glucose oxidase (GOX) layer thickness outside of specification (5.5 to 9.2 m). A non-conforming GOX layer thickness could impact sensor function (sensor glucose value) or loss of sensor function due to the sensor layer being too thin. The potential impact resulting from this issue ranges from user inconvenience to over/under delivery of insulin, possibly resulting in hyperglycemia or hypoglycemia, if the sensor glucose values are affected. The issue was identified by the manufacturing team during the execution of Filmetrics Measurement for a Guardian Sensor lot.

On 11/15/23, recall notices were mailed or emailed to patients, distributors, and healthcare professionals who were told the following: 1) If you have affected devices discard and contact the firm to receive replacement sensors in the following ways: by completing the web form at medtronicdiabetes.com/G4S-form, contacting 24-Hour Technical Support at 800-646-4633, option 1, or email [email protected]. 2) If you cannot identify the LOT number of the sensor you are currently wearing, remove the sensor and replace your sensor with a non-impacted sensor. 3) Please complete and return the confirmation form via email to [email protected] Distributors were asked to either 1) notify impacted customers using the Correction Letter and provide status updates to the recalling firm regarding customer responses, or 2) provide the recalling firm with customer addresses so they can notify impacted customers. If you have any questions, please contact the firm at 800-646-4633, option 1.