Class 2 Device Recall LASSO NAV DUO LOOP eco Catheters

• Date Initiated by Firm: February 25, 2015
• Date Posted: March 03, 2015
• Recall Status: Terminated on October 16, 2015
• Recall Number: Z-1242-2015
• Recall Event ID: 70590
• 510(K)Number: K130602
• Product Classification: Catheter, electrode recording, or probe, electrode recording - Product Code DRF
• Product: LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart. LASSO NAV DUO LOOP eco Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.
• Code Information: All lots manufactured as of February 24, 2015 are affected.
• 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 LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.
• FDA Determined Cause: Device Design
• Action: Biosense Webster sent an Urgent Voluntary Medical Device Recall letter dated February 24, 2015 , to all affected customers. The letter informed customers that Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover. The letter informed the customers of the problems identified and the actions to be taken. Customers with questions were instructed to contact Biosense Webster sales representatives or call (866) 473-7823, Monday through Friday from 7am to 8pm EST. Customers with questions related to the Voluntary Field Removal Certification Form and its return, are instructed to call (909) 839-8468. For questions regarding this recall call 909-839-8500.
• Quantity in Commerce: 464 units
• Distribution: Nationwide Distribution
• 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