Medtronic recalls Guardian Sensor kits for inaccurate glucose readings when used with hydroxyurea. Affected kits have specific packaging codes; no remedy provided in recall notice.
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 kits that may give inaccurate high glucose readings when used with hydroxyurea. This could lead to incorrect diabetes management decisions if the patient is taking this chemotherapy drug.
The Guardian Sensor kit may show falsely high glucose levels when used with hydroxyurea. This could cause patients to take unnecessary insulin or other diabetes medications, leading to dangerous blood sugar levels.
People with diabetes using Medtronic Guardian Sensor kits who also take hydroxyurea chemotherapy may be affected. Those with diabetes and hydroxyurea use are most at risk.
Check for packaging with GS3 SEMI 5PK OUS or GTIN 20763000192086, or GS3 OUS with GTIN 20763000358451. The product is not distributed in the US.
Look for specific packaging codes listed in the recall notice.
No, the product is not distributed within the US.
The Guardian Sensor kit may give inaccurate elevated glucose readings when used with hydroxyurea chemotherapy.
The recall notice does not provide a remedy; check packaging to see if you have an affected kit.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1606-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1606-2021 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.
