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

FDA device recall Z-2369-2012 · posted 2012-09-12 · Terminated

Recall details

Recalling firm

Biosense Webster, Inc.

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.

Action taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

DQK

Quantity affected

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.

Date initiated

2009-11-17

Date posted

2012-09-12

Date terminated

2012-09-12

Location

Irwindale, CA

Related 510(k) clearances