Medtronic recalls Guardian Sensor (3) devices for inaccurate elevated 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 Guardian Sensor (3) devices that may give inaccurate high glucose readings when used with hydroxyurea. This could lead to incorrect diabetes management decisions. The recall covers specific packaging details.
The sensor may show falsely high glucose levels when used with hydroxyurea. This could cause unnecessary insulin adjustments or missed low blood sugar events. Inaccurate readings might lead to health risks if not corrected.
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 labeled GS3 5PK US GC with GTIN 20763000179629. The device is intended for use with Medtronic Diabetes glucose monitoring systems.
Look for the specific packaging label GS3 5PK US GC with GTIN 20763000179629.
The Guardian Sensor (3) may give inaccurate elevated glucose readings when used with hydroxyurea, an anti-cancer drug.
No, but you should check if you have the specific packaging label mentioned in the recall.
Check your device packaging for the specific label. If you have it, 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-1603-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1603-2021 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.
