Medtronic Guardian Sensor 3 Recalled for Inaccurate Glucose Readings
Medtronic is recalling Guardian Sensor 3 units because use with 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 where a specific drug interaction can lead to inaccurate readings, posing a risk of harm to patients with diabetes, but no injuries or illnesses have been reported.
Plain-English summary
Medtronic Inc. is recalling 13,014 units of the Guardian Sensor 3 (REF: MMT-7020D3) for worldwide distribution. The recall includes specific packaging configurations identified by GTINs 00643169704121 and 00763000318895. 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, an anti-neoplastic drug, could result in inaccurate elevated sensor glucose readings. The source text does not report any specific illnesses or injuries associated with this issue.
Consumers should stop using the affected sensors if they are currently taking hydroxyurea and 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-7020D3 Guardian Sensor (3) for the following packaging: GS3 1 PK OUS3/ GTIN: 00643169704121 GS3 1PK 9L OUS3/ GTIN: 00763000318895 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose…
- Manufacturer
- Medtronic Inc.
- Affected units
- 13,014
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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