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 Guardian Sensor (3) glucose monitors that may give inaccurate high readings when used with hydroxyurea, an anti-cancer drug. 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 incorrect diabetes treatment decisions, potentially leading to health risks.
People with diabetes who take hydroxyurea may be affected. Those using the Guardian Sensor (3) with hydroxyurea are at risk of inaccurate glucose readings.
Check for packaging codes: GS3 5PK OUS1 with GTIN 20643169704071, or GS3 5PK 9L OUS1 with GTINs 20763000243320 or 20763000318844. The product is not distributed in the US.
Look for specific packaging codes: GS3 5PK OUS1 with GTIN 20643169704071, or GS3 5PK 9L OUS1 with GTINs 20763000243320 or 20763000318844.
No, the product is not distributed within the US.
Using the Guardian Sensor (3) with hydroxyurea can cause inaccurate elevated glucose readings.
No, but you should check if you have the affected packaging codes and contact Medtronic for guidance.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1607-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1607-2021 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.
