Z-2369-2012Class II

CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular...

Name: Z-2369-2012 CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular...
Creator: Biosense Webster, Inc.
Published: 2009-11-17
License: https://open.fda.gov/license/

Biosense Webster Inc / initiated 2009-11-17 / Terminated / root cause: labeling and UDI

FDA source

Biosense Webster, Inc. began a recall of 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... on 2009-11-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2369-2012
Classification: Class II
Status: Terminated
Initiated: 2009-11-17
Posted: 2012-09-12
Terminated: 2012-09-12
Recalling firm: Biosense Webster Inc
Product: 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.
Product code: DQK Computer, Diagnostic, Programmable
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: 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.
Quantity in commerce: 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.
Product codes and lots: FG-5400-00

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2369-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2369-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-12

Product code DQK

K090017Class IICarto 3 Ep Navigation System, V1.0 and AccessoriesBiosense Webster, Inc. / cleared 2009-10-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)