Medtronic Guardian Sensor 3 Recalled for Inaccurate Readings with Hydroxyurea
Medtronic is recalling Guardian Sensor 3 units 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 risk-of-harm product (medical device) where inaccurate readings could lead to improper diabetes management, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic Inc. is recalling 1,224,032 units of the Guardian Sensor (3) (REF: MMT-7020A). 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 5PK 2L US) with GTINs 20763000140940 and 20763000337005. 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 glucose monitoring for patients using both the device and the medication.
Consumers using the Guardian Sensor (3) who are also taking hydroxyurea should stop using the device and contact their healthcare provider or Medtronic for further instructions. Patients should consult their healthcare provider regarding alternative methods for glucose monitoring while on this medication.
The recalled product
- Product
- Medtronic REF: MMT-7020A, Guardian Sensor (3) for the following packaging: GS3 5PK 2L US/ GTIN: 20763000140940 GS3 5PK 2L US/ GTIN: 20763000337005 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose…
- Manufacturer
- Medtronic Inc.
- Affected units
- 1,224,032
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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