Biosense Webster, Inc.: Medical Device Recall in 2015 - (Recall #: Z-0002-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 10, 2015

Date Posted: October 7, 2015

Recall Number: Z-0002-2016

Event ID: 72167

Reason for Recall:

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 Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added.

Status: Terminated

Product Quantity: 1035 (U.S.)

Code Information:

Catalog #: C3SOUND, 10439236, 10439072, 10439011, 10438577

Distribution Pattern:

Worldwide Distribution. US nationwide, Italy, Canada, Japan, China, Singapore, Colombia, England, Russia, Spain, France, Germany, Finland, Ireland, Australia, Sweden, Hungary, India, Brazil, Slovenia, Netherlands, Mexico, and South Africa.

Voluntary or Mandated:

Voluntary: Firm initiated