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

Starting date:

April 4, 2014

Posting date:

May 5, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-39309

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  Reason
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  Affected products

Recalled Products

A. C3 - Thermocool SF Nav Bi-Directional Catheter

B. Carto XP-Thermocool SF Nav Bi-Directional Catheter

C. Thermocool SF Nav Uni-Directional Catheter

Reason

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.

Affected products