Medtronic recalls Enlite Glucose Sensors (GTINs 00643169541719, 00643169786738, 00763000421304) that may give inaccurate high glucose readings when used with hydroxyurea. Affected users should 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 Enlite Glucose Sensors that may show falsely high glucose levels when used by people taking hydroxyurea. This could lead to incorrect diabetes management decisions if the sensor readings are trusted.
The sensors may show higher glucose levels than actual when used with hydroxyurea. This could cause users to take unnecessary insulin or other diabetes treatments, leading to potential complications.
People with diabetes who use Medtronic Enlite Glucose Sensors and are taking hydroxyurea may be affected. Those who use the sensors without hydroxyurea are not at risk.
Check for the following packaging: ENLITE PLUS 23L 1CL (GTIN: 00643169541719), ENLITE PLUS 2L 1CL (GTIN: 00643169786738), or ENLITE PLUS 1PK 23L 1CL (GTIN: 00763000421304).
Look for the specific GTIN numbers listed in the recall notice to confirm if your sensor is affected.
No, the recall does not require immediate discontinuation. Affected users should contact Medtronic for guidance.
The recall does not specify a remedy. Contact Medtronic directly for instructions on next steps.
The recall states that use with hydroxyurea may cause inaccurate readings, so users should be cautious and consult their healthcare provider.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-1600-2021 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-1600-2021 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.
