Events

Alerte De Sécurité sur AMPLATZER TorqVue FX Delivery System

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par St Jude Medical.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-02-14
  • Date de publication de l'événement
    2013-02-14
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130214a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: st jude medical amplatzer torqvue fx delivery system the food and drugs administration (fda), united states posted a medical device safety alert concerning amplatzer torqvue fx delivery system [model no.: 9-itvfx06f45/60, 9-itvfx07f45/60, 9-itvfx007f45/80, 9-itvfx08f45/60, 9-itvfx08f45/80, 9-itvfx09f45/80, 9-itvfx10f45/80, 9-itvfx12f45/80, 9-itvfx13f45/80] manufactured by st jude medical. the product was manufactured 24 august 2012 to 24 september 2012 and distributed 1 october 2012 – 9 january 2013. in a small number of cases, the distal end of the core wire of the torqvue fx delivery system could potentially fracture. this product may cause serious adverse health consequences, including death. the manufacturer advised customers to stop using the device and remove it from their inventory. according to the local supplier, the affected devices were not distributed in hong kong. for details, please visit the following fda website: http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm339458.Htm if you are in possession of the product, please contact your supplier for necessary actions. posted on 14 february 2013.

Device

AMPLATZER TorqVue FX Delivery System
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    Medical Device Safety Alert: St Jude Medical AMPLATZER TorqVue FX Delivery System
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    DH