Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction
Medtronic is recalling Guardian Sensor 3 units because use with hydroxyurea may cause inaccurate 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 involves a medical device where a specific drug interaction could lead to inaccurate readings, posing a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic Inc. is recalling 15,162 units of the Guardian Sensor (3) (REF: MMT-7020D2) due to a potential interaction with the anti-neoplastic drug hydroxyurea. The recall covers specific packaging configurations (GS3 1PK 9L OUS2) with GTINs 00763000243357 and 00763000318871. The product is intended for use with Medtronic Diabetes glucose sensing systems to continuously monitor glucose levels in persons with diabetes.
The recall is issued because using the continuous glucose monitoring system while actively taking hydroxyurea could result in inaccurate elevated sensor glucose readings. This inaccuracy poses a risk to patients who rely on the device for diabetes management.
The source text notes that the product was not distributed within the US, with worldwide distribution reported. All lot numbers within the active shelf life are affected. Consumers and healthcare providers should consult with their medical professionals regarding the use of this device if hydroxyurea is being administered.
The recalled product
- Product
- Medtronic REF: MMT-7020D2 Guardian Sensor (3) for the following packaging: GS3 1PK 9L OUS2/ GTIN: 00763000243357 GS3 1PK 9L OUS2/ GTIN: 00763000318871 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucos
- Manufacturer
- Medtronic Inc.
- Affected units
- 15,162
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.
See all 20 products in this recall →Related recalls
Same manufacturer · Medtronic Inc.
See all →- HighMedtronic Sphere-9 Catheter may cause ventricular fibrillation with Biotronik ICDs
FDA (Devices) · 2026-05-06
- HighVenous stents recalled over a nitinol anomaly that reduces deployed diameter
FDA (Devices) · 2026-01-21
- ModerateKidney tests recalled for distribution without premarket approval or clearance
FDA (Devices) · 2025-12-10
- HighSmartSync Patient Connector limited the window to abort high voltage therapy
FDA (Devices) · 2025-07-30
- HighCareLink SmartSync limited the window to abort a high voltage therapy
FDA (Devices) · 2025-07-30
Same hazard · inaccurate reading
See all →- HighMedtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interference
FDA (Devices) · 2021-05-26
- HighMedtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction
FDA (Devices) · 2021-05-26
- HighMedtronic Guardian Sensor 3 Recalled for Inaccurate Glucose Readings
FDA (Devices) · 2021-05-26
- HighMedtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interference
FDA (Devices) · 2021-05-26
- HighMedtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interaction
FDA (Devices) · 2021-05-26