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/ Manufacturer |
Biosense Webster, Inc. 15715 Arrow Hwy Irwindale CA 91706-2006
|
For Additional Information Contact |
909-839-8500
|
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.
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