Agency classClass IIOur severity:High FDA (Devices)·Z-1602-2021·Announced 2021-05-26

Medtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interference

Medtronic is recalling Guardian Sensor 3 units because use with the drug hydroxyurea can cause inaccurate, elevated glucose 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 the hazard involves a risk of harm (inaccurate glucose readings) for a high-risk population (diabetes patients) without reported illnesses or injuries in the source text.

Plain-English summary

Medtronic Inc. is recalling 302,667 units of the Guardian Sensor (3) (REF: MMT-7020B). The affected products are intended for use with Medtronic Diabetes glucose sensing systems to continuously monitor glucose levels in persons with diabetes. The recall includes specific packaging configurations (GS3 1PK 2L US) with GTINs 00763000140779 and 00763000337049. All lot numbers within the active shelf life are affected, and the products were distributed worldwide.

The recall is being conducted because the use of the continuous glucose monitoring system while actively taking hydroxyurea, an anti-neoplastic drug, could result in inaccurate elevated sensor glucose readings. This interaction may lead to incorrect monitoring of blood glucose levels for patients using the device in conjunction with this specific medication.

Consumers and healthcare providers should discontinue use of the affected Guardian Sensor (3) units if they are currently taking hydroxyurea. Users should consult with their healthcare provider regarding alternative methods for glucose monitoring. Medtronic is the firm responsible for this recall.

The recalled product

Product: Medtronic REF: MMT-7020B, Guardian Sensor (3) for the following packaging: GS3 1PK 2L US/GTIN: 00763000140779 GS3 1PK 2L US/ GTIN: 00763000337049 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose…
Manufacturer: Medtronic Inc.
Category: Medical Device — Continuous Glucose Monitor
Hazard: inaccurate-reading
drug-interaction
Affected units: 302,667

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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