Medtronic Guardian Sensor 3 Recall Due to Hydroxyurea Interaction
Medtronic is recalling Guardian Sensor 3 units worldwide 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 involves a medical device where a specific drug interaction could lead to inaccurate readings, posing a risk of harm to patients, but no injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic Inc. is recalling 220,661 units of the Guardian Sensor (3) (REF: MMT-7020C1) for worldwide distribution. The recall involves specific packaging configurations (GS3 5PK OUS1 and GS3 5PK 9L OUS1) with GTINs 20643169704071, 20763000243320, and 20763000318844. The product is intended for use with Medtronic Diabetes glucose sensing systems to continuously monitor glucose levels in persons with diabetes. The source notes that the product was not distributed within the US.
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.
Consumers and healthcare providers should stop using the affected sensors if they are actively taking hydroxyurea. Patients should consult their healthcare provider for alternative glucose monitoring methods. The recall covers all lot numbers within the active shelf life.
The recalled product
- Product
- Medtronic REF: MMT-7020C1 Guardian Sensor (3) for the following packaging: GS3 5PK OUS1/ GTIN: 20643169704071 GS3 5PK 9L OUS1/ GTIN: 20763000243320 GS3 5PK 9L OUS1/ GTIN: 20763000318844 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose…
- Manufacturer
- Medtronic Inc.
- Affected units
- 220,661
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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