Events

Retiro De Equipo (Recall) de Device Recall Medtronic DxTerity(TM) Diagnostic Catheter

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 Vascular.

¿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
    79591
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1479-2018
  • Fecha de inicio del evento
    2018-03-13
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162735
  • 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, intravascular, diagnostic - Product Code DQO
  • Causa
    Medtronic has determined that the french size indicator on the outer box may incorrectly reflect a 6 french size, rather than the correct 5 french size. the catheters inside the carton are the correct dxt5jl40 item, the inner pouch has all the correct labeling, and all the other information and configuration details are correct.
  • Acción
    Medtronic initiated consignee communications on 13-Mar- 2018 to Risk Managers and Health Care Professionals. US notifications were sent via 2-Day UPS delivery. OUS communications were sent per locally approved methods. Consignees are asked to quarantine and return any unused potentially affected product to Medtronic.

Device

Device Recall Medtronic DxTerity(TM) Diagnostic Catheter
  • Modelo / Serial
    UDI 20643169689309, Lot Number 60074805
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA,
  • Descripción del producto
    Medtronic DxTerity(TM) Diagnostic Catheter, JL 4.0, 6F, REF DXT5JL40
  • Manufacturer
    Medtronic Vascular

Manufacturer

Medtronic Vascular
  • Dirección del fabricante
    Medtronic Vascular, 35-37A Cherry Hill Drive, Danvers MA 01923-2565
  • 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