Medtronic recalls Guardian Sensor (3) devices for inaccurate elevated glucose readings when used with hydroxyurea. Affected units have specific packaging labels. Contact Medtronic for details.
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 Guardian Sensor (3) glucose monitors that may give inaccurate high readings when used with hydroxyurea medication. This could lead to incorrect blood sugar management decisions.
The sensor may show falsely high glucose levels when used with hydroxyurea. This could cause unnecessary insulin doses or missed low blood sugar events. The risk occurs during normal use with the medication.
People using Medtronic Guardian Sensor (3) devices with hydroxyurea treatment for cancer. Those with diabetes who take hydroxyurea are most at risk.
Check for packaging labels with GS3 5PK 2L US and GTIN numbers 20763000140940 or 20763000337005. The device is intended for diabetes monitoring with Medtronic systems.
Look for specific packaging labels with GS3 5PK 2L US and GTIN numbers 20763000140940 or 20763000337005.
The Guardian Sensor (3) may show inaccurate elevated glucose readings when used with hydroxyurea, an anti-cancer drug.
No, but you should check if your device is affected and follow the recall instructions.
Check your device packaging for specific GTIN numbers. Contact Medtronic for further instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1601-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1601-2021 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.
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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.
