CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ...
FDA Recall #Z-2369-2012 — Class II — November 17, 2009
Product Description
CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the System's display screen. The CARTO 3 V1.05 System is also intended to support EP procedures, maintaining CARTO¿ XP System capabilities, in the presence of a high metallic environment and provide a data communication channel to the Stereotaxis Niobe Catheter Guidance System as well as in a regular EP lab. The CARTO 3 V1.05 System includes the CartoMerge capability to import, register and merge CT or MRI structural images with CARTO Maps physiological information and real time catheter navigation, the Fast Anatomical Mapping (FAM) functionality, enabling creation of cardiac maps using'catheters with magnetic proximal and distal location sensors and the CartoSound image integration functionality, that enables integration of intracardiac echo (ICE) visualization to provide 3D combined maps. In addition to the use of specialized navigation catheters, the system is also intended for use with non-navigational electrophysiology catheters.
Reason for Recall
The recall was initiated because Biosense Webster has become aware of information regarding a potential hazard that may occur during the operation of a Bloom EP Stimulator device in conjunction with RF generators and other electrophysiology (EP) equipment, including the CARTO 3 Electropysiology Mapping System.
Recalling Firm
Biosense Webster, Inc. — Irwindale, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
71 units total (30 units in US)
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Denmark, France, Germany, Israel, Italy, Netherlands, and United Kingdom.
Code Information
FG-5400-00
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated