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Health Canada Medical devices

CardioMEMS™ Patient Electronics System

Issued November 2, 2023
Issue
Abbott recently observed an increase of reports (complaints) in which the power connector plug became frayed or damaged over time. Damage and fraying of the power connector plug can occur with repeated bending or manipulation beyond 90 degrees. Fraying can rarely result in wires becoming exposed. The current report (complaint) rate has remained very low. Recall start date: October 4, 2023
Hazard description
Performance
Product
Product name
CardioMEMS™ Patient Electronics System
Reference
ID
RA-74514