Medtronic recalls Guardian Sensor (3) for potential inaccurate glucose readings when used with hydroxyurea. Affected units have specific packaging details. Contact Medtronic for remedy.
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) devices because they may give inaccurate high glucose readings when used by people taking hydroxyurea. This could lead to incorrect diabetes management decisions. The recall covers specific packaging with GTIN 763000336998.
The Guardian Sensor (3) may show falsely high glucose levels when used with hydroxyurea. This could cause users to take unnecessary actions like eating more sugar or adjusting insulin incorrectly. The risk is specific to people taking hydroxyurea.
People with diabetes who take hydroxyurea medication and use the Guardian Sensor (3) device are affected. Those with diabetes and hydroxyurea treatment are most at risk.
Check for the packaging label GS3 1PK US with GTIN 763000336998. The device is intended for use with Medtronic Diabetes glucose monitoring systems.
Look for the GS3 1PK US packaging with GTIN 763000336998 on the product.
The Guardian Sensor (3) may give inaccurate elevated glucose readings when used with hydroxyurea, an anti-neoplastic drug.
Check the packaging for GS3 1PK US with GTIN 763000336998. Contact Medtronic for further instructions.
The recall is for potential inaccurate readings, not a direct risk of injury. The hazard is specific to hydroxyurea users.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1605-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1605-2021 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.
