Agency classClass IIOur severity:High FDA (Devices)·Z-1600-2021·Announced 2021-05-26

Medtronic Enlite Glucose Sensor Recalled for Inaccurate Readings with Hydroxyurea

Medtronic is recalling Enlite Glucose Sensors because use with hydroxyurea can 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 involves a medical device where a specific drug interaction can lead to inaccurate readings, posing a risk of harm to patients with diabetes, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Medtronic Inc. is recalling 20,913 units of the Enlite Glucose Sensor (REF: MMT-7008B) due to a potential for inaccurate elevated sensor glucose readings. The recall includes specific packaging configurations: ENLITE PLUS 23L 1CL, ENLITE PLUS 2L 1CL PR, and ENLITE PLUS 1PK 23L 1CL. The affected units were distributed worldwide and include all lot numbers within their active shelf life.

The recall is issued because using the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug, could result in these inaccurate readings. This interaction may affect the reliability of glucose monitoring for patients using the device in conjunction with this specific medication.

Consumers and healthcare providers should stop using the affected Enlite Glucose Sensors if they are currently taking hydroxyurea. Patients should consult their healthcare provider for alternative glucose monitoring methods or further instructions regarding the use of their diabetes management system.

The recalled product

Product: Medtronic REF: MMT-7008B, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 23L 1CL / GTIN: 00643169541719 ENLITE PLUS 2L 1CL PR/ GTIN: 00643169786738 ENLITE PLUS 1PK 23L 1CL/ GTIN: 00763000421304 Product Usage: intended for use with Medtronic Diabetes…
Manufacturer: Medtronic Inc.
Category: Medical Device — Continuous Glucose Monitor
Hazard: inaccurate-reading
drug-interaction
Affected units: 20,913

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.

See all 20 products in this recall →

Same manufacturer · Medtronic Inc.

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