Events

Retiro De Equipo (Recall) de DLP Pericardial/Intracardial Sump

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 Revascularization & Surgical Therap.

¿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
    50173
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0609-2009
  • Fecha de publicación del evento
    2009-01-26
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-05-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74901
  • 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
    Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing - Product Code DWF
  • Causa
    Separates: six complaints were received from two locations. in all cases the sump tip assembly separated from the tubing during device removal and had to be retrieved from the patient. there were no adverse events affecting these patients.
  • Acción
    Consignees were sent a "Medtronic Urgent Medical Device Recall Notice" dated October 1, 2008. The letter described the product and issue. It also requested its customers to return the product and to complete, sign and fax the Recall Certificate "Medtronic Recall Certificate (FCA 0902)". For further information, please contact Medtronic Cardiovascular Revascularization & Surgical Therap by telephone at 763-391-9000.

Device

DLP Pericardial/Intracardial Sump
  • Modelo / Serial
    Lot number 2006100305
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution --- including states of NC, PA, IA, WI, IN, VA, IL, KY, and TX, and countries of Australia, France, Hong Kong, Netherlands, and Poland.
  • Descripción del producto
    DLP(R) Pericardial/Intracardiac Sump Cannulae, 20 Fr., P/N: 12112. This product is intended for draining the pericardial sac or the cardiac chambers.
  • Manufacturer
    Medtronic Cardiovascular Revascularization & Surgical Therap

Manufacturer

Medtronic Cardiovascular Revascularization & Surgical Therap
  • Dirección del fabricante
    Medtronic Cardiovascular Revascularization & Surgical Therap, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • 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