Device Recall LASSO NAV DUO LOOP eco Catheters

  • Model / Serial
    All lots manufactured as of February 24, 2015 are affected.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • Manufacturer Parent Company (2017)
  • Source
    USFDA