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 using them with hydroxyurea (an anti-cancer drug) can cause inaccurate high glucose readings. This could lead to incorrect diabetes management decisions.
The sensor may give falsely high glucose readings when used with hydroxyurea. This could cause patients to take unnecessary insulin or skip doses, leading to dangerous blood sugar levels.
People using Medtronic Guardian Sensor (3) devices with hydroxyurea treatment are affected. Those with diabetes who take hydroxyurea are at higher risk of incorrect glucose readings.
Check for packaging codes: GS3 5PK OUS3 with GTIN 20643169704118, or GS3 5PK 9L OUS3 with GTINs 20763000243368 or 20763000318882. The product is not sold in the US.
Look for specific packaging codes listed in the recall notice to confirm if your device is affected.
Reach out to Medtronic directly for further instructions on how to address the issue.
No, the product is not distributed within the US.
Hydroxyurea can cause the sensor to give inaccurate elevated glucose readings, which may lead to incorrect diabetes management.
Check your device packaging for the specific codes listed in the recall notice and contact Medtronic for further instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1609-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1609-2021 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.
