Events

Rappel de Device Recall ISMUS CATH Mapping Catheter with Auto ID Technology,

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
    58884
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2664-2011
  • Date de mise en oeuvre de l'événement
    2011-05-23
  • Date de publication de l'événement
    2011-06-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-10-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100470
  • 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
    The recall was initiated because biosense webster, inc. has recently become aware that 20 electrodes catheters with auto id technology are not being recognized when connected to the carto 3 system.
  • Action
    Biosense Webster, Inc. sent a Customer Notification Letter, dated May 24, 2011, with an Acknowledgement Form and Instructions for Manually Entering the Catheter Identification in the CARTO 3 System to all US and Outside US (OUS) customers who purchased these products. For customers in the US, two letters and forms will be sent via express mail, addressed to the EP/Cardiology Lab and Risk Management Office, respectively. Instructions for manual entry of the catheter identification in the CARTO 3 System are being included in the communication to customers. These instructions will allow customers to input the identity of the catheter into the CARTO 3 System and be able to utilize the catheter. Customers were instructed to complete and return the attached Acknowledgement Form in accordance with the instructions listed on the form. Customers were instructed to contact their BWI representative for any questions.

Device

Device Recall ISMUS CATH Mapping Catheter with Auto ID Technology,
  • Modèle / numéro de série
    Catalog # D7R20P14CT
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Belgium, Japan, and Singapore
  • Description du dispositif
    ISMUS CATH Mapping Catheter with Auto ID Technology, Part Number D-1171-34-S, Catalog # || D7R20P14CT || The affected catheters are indicated for multiple electrode electrophysiological mapping of cardiac structures of the heart, i.e. recording or stimulation only.
  • 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