Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction
Medtronic is recalling Guardian Sensor 3 units worldwide because use with hydroxyurea may cause inaccurate high 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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the High severity criteria for potential harm without confirmed adverse events.
Plain-English summary
Medtronic Inc. is recalling 111,678 units of the Guardian Sensor (3) continuous glucose monitoring sensor. 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 and involves worldwide distribution.
The recall is being conducted because using 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 on this specific medication.
Consumers using the Guardian Sensor 3 who are currently taking hydroxyurea should stop using the device and consult their healthcare provider for alternative glucose monitoring methods. The source text notes that the product was not distributed within the US, but the recall applies to worldwide distribution.
The recalled product
- Product
- Medtronic REF: MMT-7020D1 Guardian Sensor (3) for the following packaging: GS3 1PK OUS1/ GTIN: 00643169704084 GS3 1PK 9L OUS1/ GTIN: 00763000243333 GS3 1PK 9L OUS1/ GTIN: 00763000318857 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing…
- Manufacturer
- Medtronic Inc.
- Affected units
- 111,678
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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