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Carto 3 V1.05(Fg-5400-00) recallZ-2369-2012 · Biosense Webster, Inc. · initiated Nov 17, 2009

Class II Terminated All recalls posted in September 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biosense Webster, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Labeling mix-ups

What the company is doing

Biosense Webster sent an " URGENT FIELD SAFETY NOTICE" dated November 20, 2009 to all affected customers who purchased the Carto 3 Electrophysiology Mapping System. The letter informed the customers of the problem identified and the actions to be taken. Customers were instructed to continue use of the CARTO 3 System and that it was safe and no further action is needed. Customers with questions about the notice were instructed to contact Biosense Webster representatives. On January 12, 2010 another letter was sent from Biosense to all their customers recommending to avoid any connection of an EP stimulator's pacing pins to the direct ports on the CARTO 3 System when applying RF energy, unless the set up is indicated by the stimulator's instructions for use. The letter also informed the customer that the user manual for the CARTO 3 System has been formally revised to include a warning. Customers were instructed to complete an acknowledgement form to confirm receipt of the revised user manual.

Recall details

Recall number
Z-2369-2012
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 17, 2009
Posted by the FDA
Sep 12, 2012
Recalling firm
Biosense Webster, Inc.
Quantity
71 units total (30 units in US)
Product code
DQK
FDA submissions
K090017
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Denmark, France, Germany, Israel, Italy, Netherlands, and United Kingdom.

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.

Code information (models, lots, serial numbers)

FG-5400-00

Other devices under the same FDA submission

6 devices cleared under K090017 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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