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Biosense Webster, Inc. recalls 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 N
Recalled March 11, 2015 · FDA recall Z-1242-2015 · Biosense Webster
Hazard
Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover. · FDA Class II
Units
464 units
Sold at
Nationwide Distribution
Description
Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.
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.
Manufacturer(s)
Biosense Webster, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →