Medtronic Enlite Glucose Sensor Recall Due to Hydroxyurea Interference
Medtronic is recalling Enlite Glucose Sensors because use with hydroxyurea may cause inaccurate elevated readings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is classified as FDA Class II and involves a risk of harm (inaccurate glucose readings) for a specific patient population, but no injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic Inc. is recalling 213,110 units of Enlite Glucose Sensors (REF: MMT-7008A) distributed worldwide. The recall covers all lot numbers within the active shelf life for specific packaging configurations, including ENLITE PLUS 5PK 23L 1CL and ENLT PLUS 5PK 2L 1CL PR.
The recall was initiated because using the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug, could result in inaccurate elevated sensor glucose readings. This interference may affect the accuracy of glucose monitoring for patients using this specific medication.
Consumers who are using these sensors and are currently taking hydroxyurea should consult their healthcare provider regarding the potential for inaccurate readings. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541706, ENLT PLUS 5PK 2L 1CL PR/ GTIN: 20643169786725, ENLITE PLUS 5PK 23L 1CL/ GTIN: 20763000421292 - Product Usage: intended for use with Medtronic Diabetes…
- Manufacturer
- Medtronic Inc.
- Affected units
- 213,110
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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