Events

Retiro De Equipo (Recall) de Device Recall Model 7305 Mosaic Aortic Obturator

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
    Recall
  • ID del evento
    67242
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0908-2014
  • Fecha de inicio del evento
    2014-01-09
  • Fecha de publicación del evento
    2014-02-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-05-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125069
  • 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
    heart-valve, non-allograft tissue - Product Code LWR
  • Causa
    Medtronic, inc. initiated a recall of medtronic mosaic aortic obturator model 7305 used with the mosaic porcine aortic bioprosthesis, model number 305, because of higher-than-expected transvalvular gradients occurring post implant.
  • Acción
    Medtronic sent an Customer Notification letter dated January 9, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Medtronic recommends surgeons continue to remain diligent in selecting the appropriate size of Mosaic Aortic Bioprosthesis. Adoption of the updated Mosaic Aortic Bioprosthesis sizing chart (iEOA chart) and Mosaic Obturators/Sizers will facilitate optimal aortic valve size selection. Your Medtronic Field Representative will be contacting you about receiving a new Mosaic Aortic Obturator/Sizer set and sizing chart. If you would prefer to order the new Mosaic Aortic Obturator/Sizer set directly through Medtronic Customer Service, contact them at 1-800-848-9300. Medtronic will notify all applicable regulatory agencies, as required, about this matter. Please share this notification with others in your organization as appropriate. We appreciate your review of this notification and apologize for the inconvenience that it may cause. If you have any questions, please contact your Medtronic Field Representative or Lifeline Technical Services at 1-877-526-7890.

Device

Device Recall Model 7305 Mosaic Aortic Obturator
  • Modelo / Serial
    Model 7305.  Lot/Serial Numbers:  The catalog numbers for the Obturator/Sizer are 7305C, 7305UX, and 7305OD.  Scope of this notification includes all Mosaic Obturators/Sizers, used with Mosaic Porcine Aortic Bioprosthesis implants.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA (nationwide)
  • Descripción del producto
    Product Name: Model 7305- Mosaic Aortic Obturator || The Mosaic Aortic Obturators are used with the Mosaic Porcine Aortic Bioprostheses.
  • Manufacturer
    Medtronic Cardiovascular Surgery-the Heart Valve Division

Manufacturer

Medtronic Cardiovascular Surgery-the Heart Valve Division
  • Dirección del fabricante
    Medtronic Cardiovascular Surgery-the Heart Valve Division, 1851 E Deere Ave, Santa Ana CA 92705-5720
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • 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
    USFDA