Agency classClass IIOur severity:High FDA (Devices)·Z-1617-2021·Announced 2021-05-26

Medtronic Enlite Glucose Sensor Recalled for Inaccurate Readings

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 involves a medical device that may provide inaccurate readings for a specific drug interaction, posing a risk of harm to patients, but no injuries or illnesses are reported in the source text.

Plain-English summary

Medtronic Inc. is recalling 1,174 units of Enlite Glucose Sensors (REF: MMT-7008C). The affected packaging is ENLITE AUS 1 PRESS 5PK with GTIN 20763000252032. 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 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. The product was distributed worldwide, but the source notes that the product was not distributed within the US.

Consumers should stop using the affected sensors if they are actively taking hydroxyurea. Users should consult their healthcare provider for alternative glucose monitoring methods. The recall is classified as Class II by the FDA.

The recalled product

Product: Medtronic, REF: MMT-7008C, Enlite Glucose Sensor for the following packaging: ENLITE AUS 1 PRESS 5PK/ GTIN: 20763000252032 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with…
Manufacturer: Medtronic Inc.
Category: Medical Device — Glucose Monitoring
Hazard: inaccurate-reading
drug-interaction
Affected units: 1,174

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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