Events

Rappel de Pipeline Embolization Device and Alligator Retrieval Device

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Covidien Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2014-RN-00415-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2014-04-04
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00415-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    Through internal testing, covidien identified certain lots of the pipeline embolization device and the alligator retrieval device that have the potential for the ptfe (polytetrafluoroethylene) coating on the delivery wire to delaminate and detach. there have been no patient injuries reported.
  • Action
    Covidien is requesting hospitals to discontinue use of the devices and segregate from other inventory. Covidien will arrange for the pick-up and return of the affected devices. This action has been closed-out on 10/02/2016.

Device

Pipeline Embolization Device and Alligator Retrieval Device
  • Modèle / numéro de série
    Pipeline Embolization Device and Alligator Retrieval DevicePipeline Embolization DeviceProduct Code: FA-77350-14V07Lot Number: 9855265ARTG Number: 186413Alligator Retrieval DeviceProduct Code: FA-88810-30V03Lot Number: 9791385ARTG Number: 190843
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien Pty Ltd
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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
    DHTGA