Events

Retiro De Equipo (Recall) de VIA 27 Microcatheters

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 Sequent Medical 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
    75211
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0114-2017
  • Fecha de publicación del evento
    2016-10-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-05-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149671
  • 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, continuous flush - Product Code KRA
  • Causa
    Sequent medical is recalling the via 27 microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed.
  • Acción
    Sequent Medical sent an Urgent Medical Device Recall letter dated September 23, 2016, to all affected customers. The letter informed customers that Sequent Medical is recalling the VIA 27 Microcatheter because it may not adequately re-sheath the interventional device into the catheter as designed. The letter informs the customers of the risk to health and actions to be taken. Customers were instructed to send all confirmation forms and questions to www.customerserviceus@sequentmedical.com. Customers with questions should call (949) 830-9600x130. For questions regarding this recall call 949-923-9400.

Device

VIA 27 Microcatheters
  • Modelo / Serial
    16031101, 16042901, 16051201, 15102107, 15102701, 15111201, 15112003, 16010403, 16011409, 16012901, 16040801, 16041501, 16052603, 16061701
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US including NY, MN, FL, MO, MD, TN, NC, OH, CA, KS, TN, WV and Internationally to Czech Republic, Germany, UK, France, Netherlands, Italy, Spain, Finland, Switzerland, Slovenia, Hungary, Northern Ireland, Turkey, and Denmark,
  • Descripción del producto
    VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 || The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro, peripheral, and coronary vasculature. The catheter is inserted into the body through a small puncture made in the skin and into a blood vessel. The VIA 27 Microcatheter is contraindicated for use with liquid embolic materials, such as n-butyl 2-cyanoacrylate or ethylene vinyl alcohol & DMSO (dimethyl sulfoxide).
  • Manufacturer
    Sequent Medical Inc

Manufacturer

Sequent Medical Inc
  • Dirección del fabricante
    Sequent Medical Inc, 11 Columbia, Aliso Viejo CA 92656-1460
  • Empresa matriz del fabricante (2017)
    Terumo Corp.
  • Source
    USFDA