Events

Rappel de VENTRICULAR ASSIST DEVICE (VAD) - TLC-II SYSTEM DRIVER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par THORATEC CORPORATION.

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
    27293
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2007-06-08
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    Some tlc-ii vad drivers exceeding 1500 hours of use have potential to stop without warning due to a variability in the brush material of the motor. affects all devices serviced or manufactured since aug/05.

Device

VENTRICULAR ASSIST DEVICE (VAD) - TLC-II SYSTEM DRIVER
  • Modèle / numéro de série
    Model Catalog: 20010-0000-081 (Lot serial: Serviced/manuf'd since Aug2005)
  • Description du dispositif
    Thoratec TLC-II Portable VAD Driver
  • Manufacturer
    THORATEC CORPORATION

Manufacturer

THORATEC CORPORATION
  • Adresse du fabricant
    PLEASANTON
  • 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
    HC