Medtronic recalls Guardian Sensor (3) models for potential inaccurate glucose readings when used with hydroxyurea. This could lead to unsafe blood sugar levels for patients taking this chemotherapy drug.
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. This could cause dangerous blood sugar levels for patients taking hydroxyurea chemotherapy.
The sensor may show falsely high glucose levels when used with hydroxyurea. This could lead to patients taking unnecessary insulin or other diabetes treatments, causing dangerous blood sugar levels.
People using Medtronic Guardian Sensor (3) glucose monitors who take hydroxyurea chemotherapy. Those with diabetes who use the device with hydroxyurea are most at risk.
Check for packaging labeled GS3 5PK 9L OUS2 with GTIN 20763000243344 or 20763000318868. The product is not sold in the US and is intended for use with Medtronic Diabetes glucose monitoring systems.
Look for packaging labeled GS3 5PK 9L OUS2 with GTIN 20763000243344 or 20763000318868.
The sensor may give inaccurate elevated glucose readings when used with hydroxyurea chemotherapy, which could lead to unsafe blood sugar levels.
No, the product is not distributed within the US.
The recall record does not specify a remedy or action steps for affected users.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1608-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1608-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
