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 medical device that may provide inaccurate data, posing a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Medtronic Inc. is recalling 37,228 units of the Guardian Sensor (3) (REF: MMT-7020LA, GTIN: 20763000336985). These continuous glucose monitoring sensors are intended for use with Medtronic Diabetes systems to monitor glucose levels in persons with diabetes. The recall covers all lot numbers within the active shelf life, and the product was distributed worldwide.
The recall was initiated 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 in conjunction with this specific medication.
Consumers who are using the Guardian Sensor 3 and are currently taking hydroxyurea should contact their healthcare provider or Medtronic for guidance on alternative monitoring methods or further instructions. The source text does not specify a particular date range or additional distribution details beyond worldwide availability.
The recalled product
- Product
- Medtronic REF: MMT-7020LA, Guardian Sensor (3) for the following packaging: GS3 5PK US/ GTIN: 20763000336985 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
- 37,228
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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