Recall Z-1617-2013— Biosense Webster, Inc.

Name: FDA recall Z-1617-2013
Creator: U.S. Food and Drug Administration
Published: 2013-06-19

Class II · Terminated

Class II FDA medical device recall by Biosense Webster, Inc., initiated 2013-06-19, terminated 2014-02-07. It names one FDA 510(k) clearance: K113213. Product: 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.. Reason: 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..

Recalling firm: Biosense Webster, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-06-19
Terminated: 2014-02-07
Firm location: Irwindale, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K113213 — LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2Biosense Webster, Inc.·cleared 2011-12-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.