Events

Retiro De Equipo (Recall) de Device Recall Greenfield Vena Cava Filter 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 Boston Scientific.

¿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
    34134
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-0280-06
  • Fecha de inicio del evento
    2005-12-02
  • Fecha de publicación del evento
    2005-12-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2007-04-02
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43177
  • 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
    Filter, Intravascular, Cardiovascular - Product Code DTK
  • Causa
    There have been reports of detachment at the bond between the carrier capsule and the outer sheath of the greenfield vena cava filters with 12 fr femoral introducer systems manufactured before marcyh 10, 2004. if the capsule should detach during an implantation procedure, there is a risk of cardiac and pulmonary embolization.
  • Acción
    Recall packages started going out 12/02/05 via Fed Ex and was completed 12/03/05. A letter was directed to several persons within each hospital . The letter describes the issues, the affected lot numbers and the complaints that Boston Scientific has received. Affected devices are to be segregated for return back to Boston Scientific. A 'Reply Verification Tracking Form' is asked to be returned back to Boston Scientific.

Device

Device Recall Greenfield Vena Cava Filter System
  • Modelo / Serial
    all codes of product manufactured before March 10, 2004. Catalog no. 50-501 with lot/batch # between 5145758 and 6387904
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    nationwide (except ND); Virgin Islands, OUS to include: united Arab Emirates, Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Chile, China, Colombia, Germany, Spain, France, Ireland, Great Britain, Israel, India, Italy, Jamaica, Jordan, Japan, Korea (South Republic), Kuwait, Lebanon, Mexico, Malaysia, Netherlands, New Zealand, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad and Tobago, Taiwan, Venezuela
  • Descripción del producto
    Stainless Steel Greenfield Vena Cava Filter with 12 Fr / 4,0 mm FlexCarrier Capsule. For Femoral Vein Introduction Only. Order No. 50-501. Sterile EO. Single Use Only. Read Instructions for Use before using this device. Distributed in USA by: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA USA 01760. Manufacturer: Boston Scientific Cork Ltd., Business & Technology Park, Model Farm Road, Cork, Ireland. The Stainless Steel Greenfield Vena Cava Filter with 12 Fr. / 4,0 mm introducer System is a permanently implanted stainless steel device designed to protect against pulmonary embolism while maintaining patency of the inferior vena cava. The Stainless Steel Greenfield Vena Cava Filter comes preloaded in a 12 Fr. / 4,0 mm jugular or femoral introducer catheter.
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Dirección del fabricante
    Boston Scientific, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Source
    USFDA