Events

Retiro De Equipo (Recall) de Device Recall TigerPaw System II

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 Laax, 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
    70853
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1462-2015
  • Fecha de inicio del evento
    2015-03-25
  • Fecha de publicación del evento
    2015-04-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135188
  • 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
    Staple, implantable - Product Code GDW
  • Causa
    Increase of field reports involving issues with the tigerpaw system ii resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the tigerpaw system ii fastener.
  • Acción
    The firm, LAAx, Inc.on behalf of Maquet Medical Systems, sent an "URGENT MEDICAL DEVICE RECALL (Removal) IMMEDIATE ACTION REQUIRED " letter dated March 30, 2015 to all affected sites by express mail. The letter describers the product, problem and actions to be taken. The customers were instructed to examine your inventory immediately to determine if you have any TIGERPAW System II products; remove the products, quarantine them and place in a secure location; complete and return the MEDICAL DEVICE RECALL (Removal) RESPONSE FORM by e-mailing a scanned copy to:Tigerpaw2015@maquet.com or FAX to: 1-(973)-396-3607. If you have acted as a distributor for the TIGERPAW System product II, immediately contact those accounts, advise them of the recall situationa and have them return all stock to you. Your Marquet Medical System USA Sales Representative will contact you to assist with the return of any product. If you have any additional questions, contact your local Maquet Medical Systems USA Sales Representative or our Customer Service at 1-888-880-2874 (6:00 AM - 5:00 PM PST).

Device

Device Recall TigerPaw System II
  • Modelo / Serial
    Part number C-TP-1509 (9 connector)  All serial numbers/lots
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of:Australia, Bahrain, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy Netherland, Norway, Poland, Qatar, Slovenia, Spain, Saudi Arabia, Sweden, Switzerland, Turkey and United Kingdom.
  • Descripción del producto
    TIGERPAW System II, || Part number C-TP-1509 (9 connector) || The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
  • Manufacturer
    Laax, Inc.

Manufacturer

Laax, Inc.
  • Dirección del fabricante
    Laax, Inc., 151 Lindbergh Ave Ste I, Livermore CA 94551-9497
  • Empresa matriz del fabricante (2017)
    Getinge AB
  • Source
    USFDA