Agency classClass IIOur severity:High FDA (Devices)·Z-1608-2021·Announced 2021-05-26

Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction

Medtronic is recalling Guardian Sensor 3 units worldwide due to a risk of inaccurate glucose readings when used with hydroxyurea.

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 could lead to inaccurate readings, representing a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Medtronic Inc. is recalling 52,196 units of the Guardian Sensor (3) (REF: MMT-7020C2) for worldwide distribution. The recall includes specific packaging configurations identified by GTINs 20763000243344 and 20763000318868. The product is intended for use with Medtronic Diabetes glucose sensing systems to continuously monitor glucose levels in persons with diabetes.

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 poses a risk of incorrect glucose monitoring for affected patients.

The recall covers all lot numbers within the active shelf life. The source text notes that the product was not distributed within the US, but the distribution pattern is listed as worldwide. Consumers and healthcare providers should stop using the affected sensors if they are actively taking hydroxyurea and consult their healthcare provider for alternative monitoring methods.

The recalled product

Product: Medtronic REF: MMT-7020C2 Guardian Sensor (3) for the following packaging: GS3 5PK 9L OUS2/ GTIN: 20763000243344 GS3 5PK 9L OUS2/ GTIN: 20763000318868 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor…
Manufacturer: Medtronic Inc.
Category: Medical Device — Continuous Glucose Monitor
Hazard: inaccurate-reading
drug-interaction
Affected units: 52,196

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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