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Health Canada Medical devices

LINQ II Insertable Cardiac Monitor (ICM)

Issued November 21, 2023
Issue
Medtronic is notifying customers of a population of LINQ II Insertable Cardiac Monitors (ICM) that underwent a manufacturing process that may allow for moisture to impact electrode performance. This may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. Recall start date: November 2, 2023
Hazard description
Performance
Product
Product name
LINQ II Insertable Cardiac Monitor (ICM)
Reference
ID
RA-74622