Medtronic recalls Guardian Sensor (3) for potential inaccurate glucose readings when used with hydroxyurea. Affected units sold in Canada with specific packaging. No remedy stated.
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 for Canada. Using these devices while taking hydroxyurea (an anti-cancer drug) could cause inaccurate high glucose readings, which might lead to dangerous health decisions.
The Guardian Sensor (3) may show falsely high glucose levels when used with hydroxyurea. This could lead to incorrect health decisions, such as taking unnecessary insulin or skipping meals, which might cause serious complications.
People in Canada who own the Guardian Sensor (3) with the specific packaging described in the recall. Those actively taking hydroxyurea are most at risk due to potential inaccurate readings.
Check for the packaging labeled 'GS3 1PK 2L CANADA' with GTIN 00763000179595. The product is only sold in Canada and not distributed in the US.
Look for the specific packaging label 'GS3 1PK 2L CANADA' with GTIN 00763000179595.
No, the product is not distributed within the US.
Using the Guardian Sensor (3) while taking hydroxyurea could cause inaccurate elevated glucose readings.
The recall does not include a remedy; check the packaging to see if it matches the described labels.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1615-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1615-2021 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.
