Product Wiki · Recalls · Health Canada — Medical Devices

Pulmonary Vein Ablation Catheter Gold (2019-03-03) — recall 44511

Health Canada — Medical Devices · Canada · 2019-03-22 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
44511
Date of alert
2019-03-22
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: As per Post Market Surveillance Report (PMSR) for PVAC GOLD/PVAC/MASC/MAAC/T-VAC Multi-Array Ablation Catheters, 10092437DOC Rev 1D: Phrenic Nerve Injury (PNI) exhibited higher occurrence of harm than predicted. PNI is a known possible complication for atrial fibrillation ablation. So, assessment to update the IFU to add warnings and precautions for PNI was made.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/pulmonary-vein-ablation-cathet

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