Product Wiki · Recalls · Health Canada — Medical Devices

CardioMEMS Patient Electronics System — recall 76358

Health Canada — Medical Devices · Canada · 2024-10-18 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
76358
Date of alert
2024-10-18
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Cardiovascular
Product type
Medical devices
Reported risk: 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
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cardiomems-patient-electronics

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.