Medtronic Simplera Sensor cap may not adhere properly to sensor
Medtronic is recalling the Simplera Sensor because the device cap label may not adhere properly to the sensor, potentially compromising its sterility. This increases the risk of infection.
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: FDA Class II device with a serious hazard—compromised sterility increases infection risk. No illnesses or injuries have been reported, which qualifies this as a risk-of-harm product where injury has not yet been reported, placing it at the High level.
Plain-English summary
Medtronic MiniMed, Inc. is recalling the Simplera Sensor (REF: MMT-5100JD1) due to a defect in the device cap label adhesion.
The device cap label may not adhere properly to the sensor. This compromises the sterility of the sensor and increases the risk of infection for users.
The affected devices were distributed outside the United States to Austria, Belgium, Italy, Spain, Switzerland, and the United Kingdom. The recall involves 1,440 units identified by Lot # HG81GLZ (GTIN: 20763000649580).
Users who have affected devices should contact Medtronic MiniMed, Inc. for instructions regarding replacement or alternative options.
The recalled product
- Product
- Medtronic, Simplera Sensor, REF: MMT-5100JD1
- Manufacturer
- Medtronic MiniMed, Inc.
- Hazard
- sterility-defect
- infection-risk
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)
- Lot # HG81GLZ/ GTIN: 20763000649580
Distribution
Distribution scope not specified by the agency.
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