Retiro De Equipo (Recall) de Covidien EEA Haemorrhoid and Prolapse Stapler Set with DST Series Technology - 3.5mm staple and 4.8mm staple devices

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic Australasia 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 II
  • 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
    Medtronic has identified the potential for improper welding of the yellow staple guide to the instrument. use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding and/or an anastomotic leak. this issue was identified during in-process quality testing at the manufacturing facility. to date, there have been no reports of serious injury related to this issue.
  • Acción
    Medtronic is advising customers to quarantine and discontinue use of the affected product immediately. Upon receipt of the Response Form provided with the Customer Letter, Medtronic will provide users with a ZRE# to return product and issue credit.


  • Modelo / Serial
    Covidien EEA Haemorrhoid and Prolapse Stapler Set with DST Series Technology - 3.5mm staple and 4.8mm staple devicesProduct Codes: HEM3335 and HEM3348Lot Numbers: N7K0692MX, N7L0594MX, N7J1145MX, N7M0837MX, N7M0837MX ARTG Number: 178674(Medtronic Australasia - Applier, surgical staple, cutting)
  • 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