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U.S. Department of Health and Human Services

Class 2 Device Recall 20Pole LASSO Nav Catheter Eco

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  Class 2 Device Recall 20Pole LASSO Nav Catheter Eco see related information
Date Initiated by Firm June 19, 2013
Date Posted June 28, 2013
Recall Status1 Terminated 3 on February 07, 2014
Recall Number Z-1617-2013
Recall Event ID 65506
510(K)Number K113213  
Product Classification Catheter, electrode recording, or probe, electrode - Product Code DRF
Product 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S.

Designed to facilitate electrophysiological mapping of the atria of the heart.
Code Information Lot # 15832314L
Recalling Firm/
Biosense Webster, Inc.
15715 Arrow Hwy
Irwindale CA 91706-2006
For Additional Information Contact
Manufacturer Reason
for Recall
Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-Pole LASSO NAV Catheter Eco by the CARTO 3 System.
FDA Determined
Cause 2
Use error
Action An Urgent Field Notice letter was sent to all their customers who purchased the 20-Pole LASSO NAV Catheter Eco. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to complete and return the attached Voluntary Field Removal Certification Form in accordance with the instructions listed on the form. Customers are instructed to contact Biosense Webster sales representatives or call (866) 473-7823, Monday-Friday from 7:00AM to 8:00 PM EST if they have any questions. For questions related to the Voluntary Field Removal Certification Form and its return, customers are instructed to contact the Field Action Coordinator, at (909) 839-8468.
Quantity in Commerce 10 units
Distribution Distributed in the states of MN, FL, and UT.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DRF and Original Applicant = BIOSENSE WEBSTER, INC.