Retiro De Equipo (Recall) de Device Recall Medtronic EnVeo R Loading 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 Medtronic Cardiovascular Surgery-the Heart Valve Division.

¿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 1
  • 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
    Aortic valve, prosthesis, percutaneously delivered - Product Code NPT
  • Causa
    Medtronic is recalling the enveo r loading systems because of the presence of particulate.
  • Acción
    An Urgent Medical Device Recall Letter dated July 2015 will be be sent to customers who purchased the EnVeo R Loading System because Medtronic has received 8 reports related to this issue out of 7347 potentially affected units. The letter informs customers of the problems identified and the actions to be taken. Customers are instructed to complete the customer confirmation certificate and to email or fax to Medtronic at (651) 367-0612 to the attention of Customer Focused Quality.


  • Modelo / Serial
    0007254814 0007266413 0007332504 0007332506 0007332508 0007332510 0007343321 0007343324 0007343327 0007350825 0007350837 0007354113 0007354245 0007366949 0007369883 0007393098 0007393101 0007408862 0007408865 0007408867 0007408869 0007428258 0007428260 0007428263 0007435169 0007439358 0007439360 0007439362 0007456292 0007456298 0007462901 0007462903 0007462905 0007476215 0007476217 0007476219 0007482219 0007482222 0007482226 0007486826 0007492356 0007495691 0007495694 0007495696 0007508883 0007508885 0007508891 0007515698 0007515700 0007515703 0007522595 0007522598 0007522600 0007522603 0007530963 0007530973 0007537892 0007537894 0007569474 0007569477 0007569482 0007573778 0007573785 0007573788 0007573791 0007579940 0007579944 0007579948 0007579951 0007592664 0007592666 0007592669 0007592672 0007598984
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - US Nationwide, Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Dominican Republic, Estonia, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Italy, Kuwait, Latvia, Lithuania, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates and United Kingdom.
  • Descripción del producto
    EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. || Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.
  • Manufacturer


  • Dirección del fabricante
    Medtronic Cardiovascular Surgery-the Heart Valve Division, 1851 E Deere Ave, Santa Ana CA 92705-5720
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source