Biosense Webster, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1045-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog No. KT-5400-124 WITH THE CARTOUNIVU MODULE, FLUOROSCOPIC CAPTURES (IMAGES AND CINE CLIPS) CAN BE IMPORTED TO AND DISPLAYED IN THE CART0 3 SYSTEM. THESE IMAGES ARE NOT FOR DIAGNOSTIC PURPOSES. WHEN FLUOROSCOPIC CAPTURES ARE INTEGRATED INTO THE CART0 3 SYSTEM MAP VIEWERS (MAP VIEWER AND ADDITIONAL VIEW), CART0 3 MAPS, MRl OR CT IMAGES, AND CATHETER VISUALIZATION ARE SUPERIMPOSED ON THE FLUOROSCOPIC CAPTURE.

Product Classification:

Class II

Date Initiated: February 12, 2014

Date Posted: February 26, 2014

Recall Number: Z-1045-2014

Event ID: 67505

Reason for Recall:

Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2.2 and V3.2.3) when used with Siemens Axiom Artis VB Fluoroscopy systems in particular procedural configurations only. If the table rotation is not returned to zero point, there is a misalignment between the Carto 3 System map display and the fluoroscopic capture.

Status: Terminated

Product Quantity: 8 units total (5 units in US)

Code Information:

Serial No. 13201, 11125, 11519, 11320, 11115.

Distribution Pattern:

Worldwide Distribution - USA including CA, KY, NJ, MA, and UT and Internationally to Belgium, Austria, and Germany.

Voluntary or Mandated:

Voluntary: Firm initiated