Medtronic recalls Enlite Glucose Sensors for patients using hydroxyurea, which may cause inaccurate elevated glucose readings. Affected units have specific packaging labels.
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 Enlite Glucose Sensors that may give inaccurate high glucose readings when used with hydroxyurea medication. This could lead to incorrect diabetes management decisions.
The sensor may show falsely high glucose levels when used with hydroxyurea, an anti-cancer drug. This could cause patients to take unnecessary actions like eating more sugar or adjusting insulin incorrectly.
People with diabetes who take hydroxyurea medication and use Medtronic Enlite Glucose Sensors are affected. Those using the sensors without hydroxyurea are not at risk.
Check for packaging labeled 'ENLITE AUS 1 PRESS 1PK' or GTIN 00763000252045. The product is not sold in the US and is only available through specific medical channels.
Look for the specific packaging label 'ENLITE AUS 1 PRESS 1PK' or GTIN 00763000252045.
No, but you should check if you're using hydroxyurea and follow the recall instructions.
Yes, the recall only affects users of hydroxyurea medication.
The sensor may show inaccurate high glucose readings when used with hydroxyurea, an anti-cancer drug.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1618-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1618-2021 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.
