FDA-Device2013-07-10Class II
20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
Biosense Webster, Inc.
Hazard
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.
Sold states
Distributed in the states of MN, FL, and UT.
Affected count
10 units
Manufactured in
15715 Arrow Hwy, N/A, Irwindale, CA, United States
Products
20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1617-2013Don't want to check this manually?
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