Events

Retiro De Equipo (Recall) de Temporary Total Artificial Heart (TAHt) with Freedom

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 SynCardia Systems 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
    71905
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2731-2015
  • Fecha de inicio del evento
    2015-08-06
  • Fecha de publicación del evento
    2015-09-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-11-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139311
  • 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
    Artificial heart - Product Code LOZ
  • Causa
    Syncardia systems, inc. is recalling freedom drivers due to a specific component of the drive mechanism may fail and cause the drive mechanism to stop pumping; resulting in the loss of life-sustaining function.
  • Acción
    SynCardia sent an Urgent Medical Device Recall letter dated August 6, 2015 to affected customers. The letter identified the purpose, reason for the voluntary recall, risk to health, how to recognize that the device may fail, actioms to be taken by the customer/user, product and distribution information and type of action by the company. Customer were instructed to completed and return Recall Acknowledgement and Receipt Form to SynCardia. A SynCardia Clinical Support Specialist or other SynCardia representative will assist customers with replacement product and returning affected product. Contact Information For Questions Mary Pat Sloan Senior Vice President Global Certification and Logistics SynCardia Systems, Inc 1992 E Silverlake Rd Tucson, AZ 85713 Direct 520-547-7470 Toll-free 866-480-1122 Ext 1308 Monday-Friday 7:30 AM to 5:00 PM Pacific/Arizona time Hotline 24/7 866-771-9437 www.syncardia.com

Device

Temporary Total Artificial Heart (TAHt) with Freedom
  • Modelo / Serial
    Part Number: 595000-001  Motor Gearbox Serial # CGI Lot # SynCardia Lot # Freedom Driver Serial # 85979-013 85979 031479 4506 85979-022 85979 031479 4506 85977-033 85977 031333 4507  85976-020 85976 031041 4514  85976-010 85976 030944 4517 85976-014 85976 030944 4517 85979-014 85979 031479 4517 85979-021 85979 031479 4517 85976-039 85976 031074 4521 85977-001 85977 031074 4521 85978-034 85978 031823 4521 85978-040 85978 031823 4521 85977-020 85977 031333 4542 85977-032 85977 031333 4542 85979-005 85979 031452 4546 85979-012 85979 031452 4546 85979-018 85979 031479 4559 85979-024 85979 031479 4559 85976-016 85976 031041 4573 85976-026 85976 031041 4573 85977-005 85977 031140 4592 85977-008 85977 031140 4592 85977-021 85977 031333 4593 85977-025 85977 031333 4593 85979-004 85979 031452 4635 85979-007 85979 031452 4635 85979-033 85979 031823 4642 85979-026 85979 031479 4645 85979-028 85979 031479 4645 85979-017 85979 031479 4653 85979-019 85979 031479 4653 85977-026 85977 031333 4661 85978-026 85978 031623 4677 85978-032 85978 031623 4677 85977-019 85977 031405 4681  85978-018 85978 031623 4700 85978-022 85978 031623 4700 85977-012 85977 031255 4720  85978-020 85978 031623 4722 85978-025 85978 031623 4722 85976-006 85976 031041 4732  85977-006 85977 031140 4756 85978-035 85978 031823 4763  85976-001 85976 030944 4782 85976-003 85976 030944 4782 85976-037 85976 031057 4784 85976-040 85976 031057 4784 85976-030 85976 031074 4785 85976-036 85976 031074 4785 85976-022 85976 031074 4788 85976-024 85976 031074 4788 85976-015 85976 031074 4790 85976-038 85976 031074 4790 85976-023 85976 031074 4791 85976-032 85976 031074 4791 85977-015 85977 031333 4792 85977-028 85977 031333 4792 85977-030 85977 031333 4793  85977-013 85977 031333 4794 85977-023 85977 031333 4794 85977-016 85977 031333 4796 85977-031 85977 031333 4796 85977-010 85977 031405 4797 85977-011 85977 031405 4797 85977-009 85977 031405 4798 85977-037 85977 031406 4798 85977-003 85977 031405 4799 85977-034 85977 031405 4799 85977-035 85977 031406 4800 85977-036 85977 031406 4800 85978-037 85978 031823 4800 85977-039 85977 031406 4801 85977-040 85977 031406 4801 85979-011 85979 031452 4802 85978-002 85978 031487 4806 85978-004 85978 031487 4806 85978-003 85978 031487 4808 85978-006 85978 031487 4808 85979-029 85979 031541 4809 85979-031 85979 031541 4809 85978-010 85978 031541 4810 85979-038 85979 031541 4810 85978-009 85978 031541 4811 85979-034 85979 031541 4811 85979-032 85979 031541 4812 85979-035 85979 031541 4812 85978-008 85978 031541 4813 85979-036 85979 031541 4813 85978-016 85978 031623 4814 85978-021 85978 031623 4814 85978-013 85978 031623 4815 85978-024 85978 031623 4815 85978-027 85978 031623 4817 85978-030 85978 031623 4817 85978-017 85978 031623 4818 85978-029 85978 031623 4818
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- US Nationwide in the states of AR, NC, CA, OH, PA, TX, MI, and VA; and the countries of Germany, Turkey and France.
  • Descripción del producto
    Temporary Total Artificial Heart (TAH-t) with Freedom Driver System || REF 595000-001 || Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.
  • Manufacturer
    SynCardia Systems Inc.

Manufacturer

SynCardia Systems Inc.
  • Dirección del fabricante
    SynCardia Systems Inc., 1992 E Silverlake Rd, Tucson AZ 85713-3865
  • Empresa matriz del fabricante (2017)
    Tah Windown Inc.
  • Source
    USFDA