FDA-Device2025-10-08Class II

Medtronic, Simplera Sensor, REF: MMT-5100JD1

Medtronic MiniMed, Inc.
Hazard

The device cap label may not adhere to the sensor, compromising the sterility of the sensor, and increasing the risk of infection.

Sold states
US: No distribution OUS: Austria, Belgium, Italy, Spain, Switzerland, United Kingdom
Affected count
1,440 units
Manufactured in
18000 Devonshire St, N/A, Northridge, CA, United States
Products
Medtronic, Simplera Sensor, REF: MMT-5100JD1

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0033-2026

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