Events

Retiro De Equipo (Recall) de FindrWIRZ Guidewire System

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 SentreHeart 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
    75395
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0328-2017
  • Fecha de publicación del evento
    2016-11-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150382
  • 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
    Wire, guide, catheter - Product Code DQX
  • Causa
    A complaint was received on september 27th, 2016 at a medical center in germany for delamination and flaking of the ptfe lubricious coating on three findrwirz guidewire system .025 guidewires removed from their packaging hoops.
  • Acción
    SentreHeart sent an Urgent Medical Device Voluntary Recall letter dated September 29, 2016, to all affected customers by traceable delivery method. Letters explained the issue and requested that any devices from the two affected lots be returned to SentreHEART immediately. Customers were asked to complete and return the enclosed response form as soon as possible via fax at 650-354-1204 or email to customerservice@sentreheart.com. Customers with questions were instructed to call 1-855-256-7330. For questions regarding this recall call 650-241-6008.

Device

FindrWIRZ Guidewire System
  • Modelo / Serial
    Lot# 01160568 . Lot#02160586, (no products shipped from this lot) Lot# 07160639 -150
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including MO, CA, OR, GA. NH, NY, MI, TX, MD, PA, IL, KS, NE, CT, AZ and Internationally to United Kingdom and Germany
  • Descripción del producto
    FindrWIRZ Guidewire System Catalog# 40-05 || Cardiology: || The system is intended for use in the cardiovascular system for || introduction and positioning of over the-wire catheters and therapeutic devices during interventional procedures.
  • Manufacturer
    SentreHeart Inc

Manufacturer

SentreHeart Inc
  • Dirección del fabricante
    SentreHeart Inc, 300 Saginaw Dr, Redwood City CA 94063-4743
  • Empresa matriz del fabricante (2017)
    SentreHEART Inc.
  • Source
    USFDA