Medtronic Guardian Sensor 3 Recalled for Inaccurate Readings with Hydroxyurea
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 involves a risk-of-harm product (inaccurate glucose monitoring) where specific injury or illness has not yet been reported in the source text.
Plain-English summary
Medtronic Inc. is recalling 5,571 units of the Guardian Sensor (3) (REF: MMT-7020LB, GTIN: 763000336998). 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, with worldwide distribution.
The recall was initiated 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.
Consumers using the Guardian Sensor 3 who are actively taking hydroxyurea should stop using the device and consult their healthcare provider for alternative glucose monitoring methods. Medtronic is the recalling firm for this Class II medical device recall.
The recalled product
- Product
- Medtronic REF: MMT-7020LB, Guardian Sensor (3) for the following packaging: GS3 1PK US/ GTIN: 763000336998 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
- Manufacturer
- Medtronic Inc.
- Affected units
- 5,571
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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