CARTO 3 Systems, Product Code M-4800-01 The intended use of the CARTO 3 System is catheter-based cardiac electrophysiolo

FDA device recall Z-1230-2012 · posted 2012-03-20 · Terminated

Recall details

Recalling firm

Biosense Webster, Inc.

Reason for recall

Some CARTO 3 Systems may get radio frequency interference through certain interconnected cable configurations resulting in jumping or disappearing catheter icon and/or error messages during ablation.

Action taken

Three Urgent Customer Notification recall communications were initiated 2/9/12 with Biosense forwarding the notification to customers with affected backplane cards (electrophysiology lab managers, a notification for customers with affected back plane cards (risk managers), and a notification for customers with affected backplane cards and smarttouch module along with customer acknowledgement forms. The letters provides the customers with an explanation of the problem identified and steps to take in the event that the issue is observed. If the steps provided do not resolve the issue, customers are to contact their Biosense Webster representative. A Biosense Webster representative will contact customers to schedule an appointment for the replacement of the Backplane card. Customers were instructed to complete and return the attached Acknowledgement Form in accordance with the instructions listed on the form. If customers have questions, they can contact their BWI representative.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DQK

Quantity affected

134 units total (32 units in US)

Distribution

Worldwide Distribution -- US, Japan, China, Ireland, Germany, Italy, Slovenia, Indonesia, Poland, Spain, United Kingdom, Switzerland, Belgium, and Canada.

Date initiated

2012-02-09

Date posted

2012-03-20

Date terminated

2012-09-06

Location

Irwindale, CA

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