Medtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interference
Medtronic is recalling Guardian Sensor 3 kits because use with the drug hydroxyurea may 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 involves a medical device where a specific drug interaction (hydroxyurea) causes inaccurate readings, posing a risk of harm to patients with diabetes, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic Inc. is recalling approximately 497,747 units of the Guardian Sensor (3) kit, specifically the MMT-7020C reference number. The affected packaging includes the GS3 SEMI 5PK OUS (GTIN: 20763000192086) and 5PK SF NEW GS3 OUS (GTIN: 20763000358451). These sensors are intended for use with Medtronic Diabetes glucose sensing systems to continuously monitor glucose levels in persons with diabetes. The product was distributed worldwide, and the recall includes all lot numbers within the active shelf life.
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 glucose data for patients using the device.
Consumers and healthcare providers should stop using the affected Guardian Sensor 3 kits if they are currently taking hydroxyurea. Patients should consult their healthcare provider for alternative glucose monitoring methods or further instructions regarding the use of their continuous glucose monitoring system.
The recalled product
- Product
- Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW GS3 OUS/GTIN: 20763000358451 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously…
- Manufacturer
- Medtronic Inc.
- Affected units
- 497,747
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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