Medtronic Guardian Sensor 3 Recalled for Inaccurate Readings with Hydroxyurea
Medtronic is recalling Guardian Sensor 3 units worldwide because use with the drug hydroxyurea may cause inaccurate elevated glucose readings.
What this means for you
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. The hazard involves a risk of harm (inaccurate glucose monitoring) for a high-risk population (diabetes patients) without reported illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Inc. is recalling 15,926 units of the Guardian Sensor (3) (REF: MMT-7020D5) worldwide. The product is 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 1PK 1L AUS) with GTINs 00763000252069 and 00763000414375. All lot numbers within the active shelf life are affected.
The recall is due to a risk of inaccurate elevated sensor glucose readings when the continuous glucose monitoring system is used while a patient is actively taking hydroxyurea, an anti-neoplastic drug. This interaction could lead to incorrect monitoring of blood glucose levels.
Consumers and healthcare providers should stop using the affected sensors if the patient is taking hydroxyurea. The source text does not specify a particular action for patients not taking hydroxyurea, but users should consult their healthcare provider regarding the use of the device.
The recalled product
- Product
- Medtronic REF: MMT-7020D5 Guardian Sensor (3) for the following packaging: GS3 1PK 1L AUS/ GTIN 00763000252069 GS3 1PK 1L AUS/ GTIN 00763000414375 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose le
- Manufacturer
- Medtronic Inc.
- Affected units
- 15,926
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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Same hazard · inaccurate reading
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