Events

Rappel de HYDRO LeMaitre Valvulotome Devices (intended for the treatment of vascular disorders and particularly for excising or disrupting venous valves)

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

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-2017-RN-00232-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-14
  • 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-2017-RN-00232-1
  • 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
    The manufacturer, lemaitre vascular is extending the scope of the recall of hydro lemaitre valvulotome devices undertaken in august 2016 (tga ref.: rc-2016-rn-01046-1). the centering hoops keep the head of the hydro lemaitre valvulotome centered in the vessel and prevents the valve-cutting blades from damaging the vessel wall. there have been reported issues of hoops failing to close when the device was actuated. in some cases, this issue has been discovered in-use and has led to vessel damage. if the blades are stuck in the open position, the device must be removed in the open state. the removal of the device without sheathing may cause damage to the vein either during use or when the blades pass the opening of the vessel.
  • Action
    Emergo is advising customers to immediately quarantine and return unused devices from the affected lots. Returned devices will be replaced with unaffected devices.

Device

HYDRO LeMaitre Valvulotome Devices (intended for the treatment of vascular disorders and particul...
  • Modèle / numéro de série
    HYDRO LeMaitre Valvulotome Devices (intended for the treatment of vascular disorders and particularly for excising or disrupting venous valves)Catalogue number: 1009-00Lot number: ELVH1103VExpiry date : 2021-06Catalogue Number: 1010-00Lot number: ELVH1112VExpiry date : 2021-07ARTG number: 218706
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia