Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.

Recall Insight

This FDA Devices action (record #Z-0002-2016) was formally reported on October 7, 2015, with the manufacturer initiating the action on September 10, 2015. 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 1035 (U.S.) units are affected.

The documented reason for this recall is: Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navi… Distribution data in the federal record shows the product reached: Worldwide Distribution. US nationwide, Italy, Canada, Japan, China, Singapore, Colombia, England, Russia, Spain, France, Germany, Finland, Ireland, Australia, Sweden, Hungary, India, Brazil, Slovenia, Netherlands, Mexi…. 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 11 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.