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 displa

Recall Insight

This FDA Devices action (record #Z-2369-2012) was formally reported on September 19, 2012, with the manufacturer initiating the action on November 17, 2009. It is classified under Moderate severity (Class II), with a current status of Terminated. Biosense Webster, Inc. is listed as the recalling firm, operating out of Irwindale, CA. Federal records indicate 71 units total (30 units in US) units are affected.

The documented reason for this recall is: 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 ot… Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Denmark, France, Germany, Israel, Italy, Netherlands, and United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 14 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.