Retiro De Equipo (Recall) de StraightShot Microdebrider Blades

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 that the irrigation pin used to manufacture (moulding) the hub outer tube was incorrectly placed in the mould. the use of a shorter pin resulted in blockage of the irrigation lumen of specific straightshot microdebrider blades.To date, there have been no reported injuries as a result of this issue.
  • Acción
    Medtronic is advising customers to cease use of affected product. Customers are requested to return unused units by following the instructions outlined in the Customer Letter. Medtronic is advising clinicians who may have used impacted units to monitor their patient's condition to determine if there are any signs of infection. If infection is present, the patient should seek medical attention immediately for treatment.


  • Modelo / Serial
    StraightShot Microdebrider BladesBlade Skimmer 3pk 3.5mm 22.5cmModel Number: 1883523Lot Numbers: 214388556, 214861292, HG20DTQ and HG21X3JBlade Tricut 5pk 3.5mmModel Number: 1883504Lot Numbers: 0214435413, 0214630819, 0214631786, HG1YVYF, HG1Y58E, HG21X15, HG21CX2 and HG1ZTFTBlade 3pk Skimmer Ang 18cmModel Number: 1883525Lot Numbers: HG20VDV and HG1YSR6ARTG Number: 117118
  • 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