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Health Canada Medical devices

CardioMEMS Patient Electronics System

Issued October 18, 2024
Issue
Abbott has received reports of an issue following migration of the merlin.net patient care network hf portal to the cloud environment on September 30, 2024. Since then, certain patients have been impacted, and their patient electronics system may be sending incorrect pressure readings. While the issue is being investigated, Abbott is advising users to pause using these patients' pulmonary artery pressure readings for clinical decision-making or patient management. Recall start date: October 9, 2024
Hazard description
Performance
Product
Product name
CardioMEMS Patient Electronics System
Reference
ID
RA-76358