Medtronic recalls Guardian Sensor (3) devices for inaccurate elevated glucose readings when used with hydroxyurea. Affected units have specific packaging codes. No action needed for most users.
Use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug could result in inaccurate elevated sensor glucose readings.
Medtronic is recalling its Guardian Sensor (3) continuous glucose monitors because they can give inaccurate high readings when used by people taking hydroxyurea chemotherapy. This could lead to incorrect diabetes management decisions. The recall affects specific packaging codes sold outside the US.
The Guardian Sensor (3) may show falsely high glucose levels when used with hydroxyurea. This happens because hydroxyurea affects how the sensor reads blood glucose. Inaccurate readings could lead to unsafe diabetes management decisions.
People with diabetes who take hydroxyurea chemotherapy and use the Guardian Sensor (3) device are affected. Those using the device with hydroxyurea are at higher risk of inaccurate readings.
Check for packaging codes: GS3 1PK OUS1/ GTIN: 00643169704084, GS3 1PK 9L OUS1/ GTIN: 00763000243333, or GS3 1PK 9L OUS1/ GTIN: 00763000318857. The product is not distributed in the US.
Look for specific packaging codes listed in the recall notice to confirm if your device is affected.
The device is safe for most people, but may give inaccurate readings when used with hydroxyurea. Consult your healthcare provider for personalized advice.
No action is needed for most users. Only those taking hydroxyurea should check their device packaging for the specific codes listed in the recall.
The device can show falsely high glucose readings when used with hydroxyurea, which could lead to incorrect diabetes management decisions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1612-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1612-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
