Product Wiki · Recalls · Health Canada — Medical Devices

Thermocool SF Nav Catheters - Uni and Bi-Directional (2014-04-04) — recall 51175

Health Canada — Medical Devices · Canada · 2014-05-05 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
51175
Date of alert
2014-05-05
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Biosense Webster has identified a higher frequency of spontaneously reported adverse events related to cardiac perforations and Atrio-esophageal fistula (AEF) with the Uni-directional and Bi-directional Thermocool SF Nav catheter family during the time period of January 2010 to December 2013 as compared to other Navigational Thermocool ablation catheters.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/thermocool-sf-nav-catheters-un

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