Medtronic recalls Guardian Sensor (3) models for potential inaccurate glucose readings when used with hydroxyurea. Affected units have specific packaging labels. No immediate action needed but check your device.
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) glucose monitoring devices because they may give inaccurate high readings when used with hydroxyurea, an anti-cancer drug. This could lead to incorrect blood sugar management for people taking hydroxyurea.
The sensor may show falsely high glucose levels when used with hydroxyurea. This could cause unnecessary insulin doses or incorrect blood sugar management decisions.
People with diabetes who use hydroxyurea (an anti-cancer drug) and have the specific Guardian Sensor (3) model. Those with diabetes taking hydroxyurea are most at risk.
Check for packaging with GS3 1PK 1L AUS labels and GTIN numbers 00763000252069 or 00763000414375. The product is not sold in the US and is intended for use with Medtronic diabetes systems.
Look for packaging with GS3 1PK 1L AUS labels and GTIN numbers 00763000252069 or 00763000414375.
No, but check if you have the specific packaging labels mentioned. The recall does not require immediate action.
The recall states it may cause inaccurate readings with hydroxyurea, so it's not recommended for use with this drug.
Check for packaging with GS3 1PK 1L AUS labels and GTIN numbers 00763000252069 or 00763000414375.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1616-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1616-2021 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.
