Events

Rappel de Device Recall LASSO NAV DUO LOOP eco Catheters

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Biosense Webster, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    70590
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1242-2015
  • Date de mise en oeuvre de l'événement
    2015-02-25
  • Date de publication de l'événement
    2015-03-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-10-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134091
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Catheter, electrode recording, or probe, electrode recording - Product Code DRF
  • Cause
    Biosense webster is recalling the lasso nav duo loop eco catheters because of reports of difficulty retracting and damage to the spine cover.
  • Action
    Biosense Webster sent an Urgent Voluntary Medical Device Recall letter dated February 24, 2015 , to all affected customers. The letter informed customers that Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover. The letter informed the customers of the problems identified and the actions to be taken. Customers with questions were instructed to contact Biosense Webster sales representatives or call (866) 473-7823, Monday through Friday from 7am to 8pm EST. Customers with questions related to the Voluntary Field Removal Certification Form and its return, are instructed to call (909) 839-8468. For questions regarding this recall call 909-839-8500.

Device

Device Recall LASSO NAV DUO LOOP eco Catheters
  • Modèle / numéro de série
    All lots manufactured as of February 24, 2015 are affected.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    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
    Biosense Webster, Inc.

Manufacturer

Biosense Webster, Inc.
  • Adresse du fabricant
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA