Medtronic Enlite Glucose Sensor Recall for Hydroxyurea Interaction
Medtronic is recalling 207 units of Enlite Glucose Sensors because use with hydroxyurea can cause inaccurate elevated glucose readings.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed adverse events.
Plain-English summary
Medtronic Inc. is recalling 207 units of the Enlite Glucose Sensor (REF: MMT-7008D) for the ENLITE AUS 1 PRESS 1PK packaging. The product is intended for use with Medtronic Diabetes glucose sensing systems to continuously monitor glucose levels in persons with diabetes. The recall covers all lot numbers within the active shelf life.
The recall is due to a potential interaction with hydroxyurea, an anti-neoplastic drug. Use of the continuous glucose monitoring system while actively taking hydroxyurea could result in inaccurate elevated sensor glucose readings. The source text does not report any illnesses or injuries associated with this recall.
The product was distributed worldwide, but the source explicitly notes that the product was not distributed within the US. Consumers should stop using the affected sensors if they are currently taking hydroxyurea and consult their healthcare provider for alternative glucose monitoring methods.
The recalled product
- Product
- Medtronic, REF: MMT-7008D, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 1PK; GTIN: 00763000252045 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabet
- Manufacturer
- Medtronic Inc.
- Affected units
- 207
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lot numbers within active shelf life
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 20 recalled by Medtronic Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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