Medtronic recalls Guardian Sensor (3) models with specific packaging for inaccurate glucose readings when using hydroxyurea. Affected users should 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) models with certain packaging because they may give inaccurate high glucose readings when used with hydroxyurea, an anti-cancer drug. This could lead to incorrect blood sugar management for people taking hydroxyurea.
The Guardian Sensor may show falsely high glucose levels when used with hydroxyurea. This could cause incorrect blood sugar management decisions, potentially leading to health issues.
People with diabetes who use hydroxyurea (an anti-cancer drug) and have the specific Guardian Sensor (3) models with GS3 5PK 1L AUS packaging. Those taking hydroxyurea are most at risk.
Check for packaging labeled GS3 5PK 1L AUS with GTIN: 20763000252056 or 20763000414362. The product is not sold in the US, so affected users outside the US should check their packaging.
Look for GS3 5PK 1L AUS packaging with GTIN numbers 20763000252056 or 20763000414362.
No, the product is not distributed within the US.
The Guardian Sensor may give inaccurate high glucose readings when used with hydroxyurea, an anti-cancer drug.
Contact Medtronic for details on the recall and next steps.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1611-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1611-2021 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.
