Medtronic Guardian Real-Time Monitor Recalled for Finnish Translation Error
Medtronic MiniMed is recalling 254 Guardian Real-Time Monitors distributed in Finland due to a language translation error that reverses the on-screen labels for LOW and HIGH glucose alerts.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling/translation error rather than a structural defect or contamination, fitting the 'Moderate' criteria for minor labeling errors or low-risk issues.
Plain-English summary
Medtronic MiniMed Inc. is recalling 254 units of the Guardian Real-Time Monitor, Model No. CSS7100. This medical device is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin for adults (18 years and older) with diabetes mellitus.
The recall is due to a language translation error in the Finnish language version of the device. Specifically, the on-screen Finnish translation for the Predictive Alerts setting is reversed, displaying HIGH where LOW should appear and LOW where HIGH should appear. This error could impact the user's interpretation of glucose alerts.
The affected units were distributed in Finland. Consumers with this device should check their specific unit against the list of affected lot codes provided by the manufacturer or contact Medtronic MiniMed for further instructions on how to proceed.
The recalled product
- Product
- Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management.
- Manufacturer
- Medtronic MiniMed Inc.
- Hazard
- Affected units
- 254
Distribution
Distribution scope not specified by the agency.
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