Medtronic recalls Guardian Sensor (3) devices for inaccurate elevated glucose readings when used with hydroxyurea. Affected units have specific packaging codes. 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 its Guardian Sensor (3) continuous glucose monitoring devices because they can give inaccurate high glucose readings when used by people taking hydroxyurea. This could lead to incorrect blood sugar management decisions.
The sensor may show falsely high glucose levels when used with hydroxyurea. This could cause users to make incorrect decisions about their blood sugar management, potentially leading to health issues.
People with diabetes who use the Guardian Sensor (3) device and are taking hydroxyurea medication are most at risk. The recall applies to specific packaging codes sold outside the US.
Check for packaging codes GS3 1PK 9L OUS2 with GTIN numbers 00763000243357 or 00763000318871. The product is not distributed in the US and is intended for use with Medtronic Diabetes glucose systems.
Look for packaging codes GS3 1PK 9L OUS2 with GTIN numbers 00763000243357 or 00763000318871.
The Guardian Sensor (3) can give inaccurate elevated glucose readings when used with hydroxyurea, an anti-neoplastic drug.
No, but you should check if your device is affected and contact Medtronic for guidance.
No, the product is not distributed within the US.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1613-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1613-2021 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.
