Medtronic recalls Guardian 4 Glucose Sensors with specific model numbers and lot codes due to potential glucose value errors that could cause hyperglycemia or hypoglycemia.
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.
Medtronic is recalling certain Guardian 4 Glucose Sensors that may have a glucose oxidase layer thickness outside specifications. This could lead to inaccurate glucose readings, potentially causing dangerous blood sugar levels if the sensor is not functioning properly.
The sensors may have a glucose oxidase (GOX) layer thickness outside the required range (5.5 to 9.2 micrometers). This could cause the sensor to deliver inaccurate glucose values, leading to either too much or too little insulin delivery, which might result in high or low blood sugar levels.
People using Medtronic Guardian 4 Glucose Sensors with model numbers MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, or MMT-7040MA are affected. Those with diabetes who rely on these sensors for blood glucose monitoring are most at risk.
Check if your Guardian 4 Glucose Sensor has model numbers MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, or MMT-7040MA. The specific lot codes and reference numbers are listed in the recall notice.
Verify your Guardian 4 Glucose Sensor model number against the list of affected models provided in the recall notice.
Reach out to Medtronic for guidance on whether your sensor is affected and what steps to take next.
The affected models are MMT-7040A, MMT-7040C1, MMT-7040C2, MMT-7040C3, MMT-7040D1, MMT-7040D2, and MMT-7040MA.
A defective sensor could provide inaccurate glucose readings, which might lead to over or under delivery of insulin, potentially causing hyperglycemia or hypoglycemia.
No, but you should check if your sensor is affected and contact Medtronic for guidance on next steps.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1005-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1005-2024 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
