Retiro De Equipo (Recall) de Device Recall Heartport

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 Heartport 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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, Cannula And Tubing, Vascular, Cardiopulmonary Bypass - Product Code DWF
  • Causa
    Damaged hemostasis valves that prevent or present difficulty when inserting catheters.
  • Acción
    Recall was first initiated on/about 10/2/03 by phone domestically from the Director of Marketing to the firm''s Sales Force (no phone script available). Following the initial phone call, formal recall letters were sent out on 10/6/03 to: Director of CV Suite; Director of the OR; and Director of Material Management of each hospital.


  • Modelo / Serial
    Lot Numbers 020349, 050327, 060337.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Products were distributed domestically to 45 customers in CA, DC, FL, GA, IN, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI. The products were also distributed internationally to Israel, Austria, France, Germany, Italy, Belgium, Slovenia, Spain and UK. There was one US government consignment, Veterans Affairs Palo Alto, located at Health Care System, 3801 Miranda Ave. WHSE 50, Palo Alto, CA.
  • Descripción del producto
    EndoReturn arterial cannula. The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass. The EndoReturn cannula with hemostasis valve allows for hemostatic introduction and removal of the Heartport EndoClamp aortic catheter. EndoReturn arterial cannula, 21 Fr. Product code ER21 (07043). The cannulas are also packaged in kits that have no specific lot number. The EndoReturn arterial cannula is packaged in the ''EndoCPB (Cardiopulmonary Bypass) System with Cardioplegia Catheter, Product codes ECPB211, 212, 213, 214, 231, 232. Also, the EndoCPB system without Cardioplegia Catheter, Product codes ECPB211, 212, 231, 232.
  • Manufacturer


  • Dirección del fabricante
    Heartport Inc, Route 22 West, Somerville NJ 08876
  • Source