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U.S. Department of Health and Human Services

Enforcement Report - Week of July 10, 2013

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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
Distribution Pattern Distributed in the states of MN, FL, and UT.

Product Detail

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