Events

Retiro De Equipo (Recall) de Device Recall Convoy Advanced Delivery Sheath Kits

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 Corp.

¿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
    50771
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1071-2009
  • Fecha de inicio del evento
    2008-12-24
  • Fecha de publicación del evento
    2009-04-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-04-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=77095
  • 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
    Introducer, catheter - Product Code DYB
  • Causa
    The marker band may detach from the sheath and a clinical failure could result in an embolism.
  • Acción
    The firm initiated the recall on December 24, 2009 and notified consignees via "Urgent Company Initiated Medical Device Recall - Immediate Action Required" letters which explain the reason for the recall and request the affected product be returned to the Boston Scientific Corporation Distribution Center. An amendment letter with two additional Convoy Advanced Delivery Sheath Kit models (M0045748ST0 and M0045749ST0) was sent to affected customers on January 27, 2009. Direct questions about this recall to your local Sales Representative.

Device

Device Recall Convoy Advanced Delivery Sheath Kits
  • Modelo / Serial
    Batch Numbers: S1721 4 S1899 6 S2103 9 S2287 6 S2497 2 S1724 9 S1903 2 S2105 6 S2287 7 S2513 9 S1732 2 S1913 1 S2109 5 S2295 6 S2522 7 S1733 8 S1913 2 S2115 2 S2295 9 S2524 0 S1735 6 S1913 3 S2118 9 S2296 4 S2536 0 S1737 1 S1926 5 S2123 4 S2297 1 S2553 7 S1737 2 S1930 1 S2135 6 S2299 4 S2553 8 S1737 4 S1956 3 S2151 1 S2299 5 S2555 1 S1757 4 S1962 0 S2156 4 S2301 4 S2557 8 S1766 6 S1962 1 S2161 5 S2305 1 S2562 9 S1766 7 S1964 4 S2166 4 S2306 9 S2566 1 S1766 8 S1970 4 S2166 5 S2307 0 S2566 4 S1792 6 S2015 1 S2166 6 S2308 9 S2567 6 S1792 S2015 S2180 S2309 and S2579.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution.
  • Descripción del producto
    Convoy Advanced Delivery Sheath Kit, Model Numbers: || M0045660ST0, || M0045661ST0, || M0045662ST0, || M0045663ST0, || M0045665ST0, || M0045667ST0, || M0045670ST0, || M0045672ST0, || M0045675ST0, || M0045676ST0, || M0045690ST0, || M0045890ST0, || M0045748ST0 and || M0045749ST0. || Manufactured by Thomas Medical Products, Malvern, PA. || Product is intended for use to facilitate the intracardiac placement of interventional devices.
  • Manufacturer
    Boston Scientific Corp

Manufacturer

Boston Scientific Corp
  • Dirección del fabricante
    Boston Scientific Corp, 150 Baytech Dr, San Jose CA 95134-2302
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA