Events

Rappel de Riata and Riata ST Silicone Endocardial Defibrillation Leads

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par St Jude Medical Australia 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-2013-RN-00692-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-07-05
  • 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-2013-RN-00692-1
  • 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
    This is an update to the 'hazard alert' letter in may 2012 and subsequent update in july 2012 (tga ref.: rc-2012-rn-00391-3) and highlights the following topics: (1) key studies and patient management considerations for patients with riata and riata st silicone leads; (2) the most recent riata lead evaluation study results; and (3) the 2013 1st edition product performance report (ppr).The may 2012 'hazard alert' identified that externalised conductors can occur in riata and riata st silicone leads when an abrasion results in an outer insulation breach within the vascular or cardiac systems allowing the normally contained conductors to become visible outside the lead body. externalised conductors can be a result of relative motion of the conductor cables within the lead insulation lumen, referred to as inside-out abrasion, or from external sources of abrasion, e.G. lead-to-lead abrasion, where the outer insulation is breached.
  • Action
    St Jude Medical is providing updated clinical information to treating clinicians based on the interim results from the ongoing studies on the performance of the Riata and Riata ST leads in long term clinical use related to insulation wear and lead conductor externalisation. Detailed data has been provided by the manufacturer at www.riatacommunication.com

Device

Riata and Riata ST Silicone Endocardial Defibrillation Leads
  • Modèle / numéro de série
    Riata and Riata ST Silicone Endocardial Defibrillation LeadsRiata (8Fr): Models 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592Riata ST (7Fr): Models 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042All these models have been cancelled from the ARTG
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    St Jude Medical Australia Pty Ltd

Manufacturer

St Jude Medical Australia Pty Ltd
  • 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
    DHTGA