Retiro De Equipo (Recall) de Shiley Reusable Cannula Cuffed Tracheostomy Tubes

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Covidien Pty Ltd.

¿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 I
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    Covidien has received customer reports on certain size 8 shiley reusable cannula, cuffed tracheostomy tubes that have had volume leakage and/or disconnection between the inner and outer cannulae. these events were typically observed during mechanical ventilation and represent a small fraction of the tubes distributed. if a leak and/or disconnection occur, ventilation may be adversely affected and the tracheostomy tube might require immediate replacement.
  • Acción
    Covidien is recalling affected stock and is providing phone advice concerning available alternatives.


  • Modelo / Serial
    Shiley Reusable Cannula Cuffed Tracheostomy Tubes, Product codes: 8FEN, 8LPC, 8LPC-SFenestrated, Cuffed TT, size 8Product code: 8FEN Lot Numbers: 0910000342 - 1101001558; 110201893X - 120600700XLow Pressure Cuffed TT, size 8Product Code: 8LPC Lot Numbers:0910000346 - 1101001823, 110200327X - 120600351XEVAC Low Pressure Cuffed TT, size 8Product Code: 8LPC-S Lot Numbers: 0910001002 - 1103002052, 111000400X - 120600014XARTG Numbers: 181271 & 100137
  • Clasificación del producto
  • Manufacturer


  • 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