Medtronic Guardian Sensor 3 Recall for Hydroxyurea Interaction
Medtronic is recalling Guardian Sensor 3 units because use with hydroxyurea may cause inaccurate 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 is classified as FDA Class II and involves a risk of harm (inaccurate glucose readings) without reported injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Inc. is recalling 12,624 units of the Guardian Sensor (3) (REF: MMT-7020D4). The product is intended for use with Medtronic Diabetes glucose sensing systems to continuously monitor glucose levels in persons with diabetes. The recall covers all lot numbers within the active shelf life for the specific packaging identified as GS3 1PK 2L CANADA (GTIN: 00763000179595). The source notes that this specific product was not distributed within the US, with worldwide distribution indicated.
The recall is due to a potential interaction with hydroxyurea, an anti-neoplastic drug. Use of the continuous glucose monitoring system while actively taking hydroxyurea could result in inaccurate elevated sensor glucose readings. This inaccuracy poses a risk to patients relying on the device for glucose monitoring.
Patients using this specific sensor packaging who are actively taking hydroxyurea should consult their healthcare provider regarding the recall. The source does not provide specific instructions for disposal or replacement, but the recall is classified as Class II by the FDA.
The recalled product
- Product
- Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN: 00763000179595¿ 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
- 12,624
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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