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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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Product Detail

Product Description 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
Recall Number Z-1617-2013
Classification Class II
Code Info Lot # 15832314L
Product Distributed Qty 10 units
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.

Event Detail

Event Id 65506
Product Type Devices
Status Ongoing
Recalling Firm Biosense Webster, Inc.
City Irwindale
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-19
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distributed in the states of MN, FL, and UT.