Events

Retiro De Equipo (Recall) de Device Recall PENTARAY NAV Catheter and PENTARAY NAV ECO Catheter

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Biosense Webster, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    67566
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1176-2014
  • Fecha de inicio del evento
    2014-02-20
  • Fecha de publicación del evento
    2014-03-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-10-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125726
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Catheter,intracardiac mapping,high-density array - Product Code MTD
  • Causa
    Biosense webster is recalling the pentaray nav catheter because it has the potential to have partial tip separation from the catheter shaft. biosense webster is expanding the recall on 5/1/14 to include all lots of the pentaray nav catheter and the pentaray nav eco catheter because they can lead to an insufficient bond of the distal tip to the catheter shaft.
  • Acción
    The firm, Biosense Webster, sent an "URGENT FIELD SAFETY NOTICE MEDICAL DEVICE-VOLUNTARY FIELD RECALL (REMOVAL)" letter dated February 18, 2014 to all customers who purchased the PentaRay Nav Catheter. The letter describes the product, the problems identified and the actions to be taken. The customers were instructed to read the "Description of the Problem" section carefully; immediately identify and set aside all affected lots; maintain a copy of this letter with the affected PentaRay NAV Catheters until all units are returned to Biosense Webster; complete and return the Voluntary Field Removal Certification form via mail to: Biosense Webster, Inc., Attn: Field Action Coordinator, 15715 Arrow Highway, Irwindale, CA 91706, Fax to: 909-839-8514 or email to: rkazmi@its.jnj.com; arrange for return of all affected units you may have in your inventory; pass on this notice to anyone in your facility that needs to be informed, and if any of the affected product have been forwarded to another facility, contact that facility and arrange for the return. Customers with questions related to the information provided in the customer notification, are instructed to contact their Biosense Webster sales representative or call (866)473-7823, Monday through Friday from 7am to 8pm EST. Customers with questions related to the Acknowledgement form and its return, are instructed to contact the Field Action Coordinator at (909) 839-8468. Biosense Webster expanded the recall on 5/1/14 by sending a customer notification letter to all customers on 5/2/14 to include all product lots of the Pentaray Nav Catheter (Catalog No: D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211). The letter provides important information about the affected products and instructions on how the customers can return the affected products to Biosense Webster.

Device

Device Recall PENTARAY NAV Catheter and PENTARAY NAV ECO Catheter
  • Modelo / Serial
    Lot Numbers: All Lots
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution.
  • Descripción del producto
    PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Catalog No. D128201, D128202, D128204, D128205, D128207, D128208, D128210, D128211. || The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
  • Manufacturer
    Biosense Webster, Inc.

Manufacturer

Biosense Webster, Inc.
  • Dirección del fabricante
    Biosense Webster, Inc., 15715 Arrow Hwy, Irwindale CA 91706-2006
  • Empresa matriz del fabricante (2017)
    Johnson & Johnson
  • Source
    USFDA