Medtronic recalls Guardian Sensor (3) devices for potential inaccurate glucose readings when used with hydroxyurea medication. 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 Guardian Sensor (3) glucose monitors that may give inaccurate high readings when used with hydroxyurea medication. This could lead to incorrect diabetes management decisions if the device is used while taking hydroxyurea.
The Guardian Sensor (3) may show falsely high glucose levels when used with hydroxyurea. This could cause unnecessary insulin doses or missed doses if the user relies on the device for accurate readings.
People with diabetes using hydroxyurea medication who have the Guardian Sensor (3) device may be affected. Those with diabetes on hydroxyurea are at highest risk.
Check for the GS3 5PK US packaging with GTIN 20763000336985. The device is intended for use with Medtronic Diabetes glucose monitoring systems.
Look for the GS3 5PK US packaging with GTIN 20763000336985 on the device.
The recall states that use with hydroxyurea could result in inaccurate elevated readings, so it's not safe to use with hydroxyurea.
The recall does not specify a remedy, so contact Medtronic directly for guidance.
Check for the GS3 5PK US packaging with GTIN 20763000336985.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1604-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1604-2021 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.
