Events

Rappel de AMPLATZER TORQVUE DELIVERY SYSTEM W/PUSHER CATHETER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par AGA MEDICAL 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
    68277
  • Classe de risque de l'événement
    I
  • Date de mise en oeuvre de l'événement
    2006-10-13
  • 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
    Aga has found that microscopic tears can occur in the sterile packaging under accelerated stress testing with routine shipping configurations. these tears are potential breach of the sterile barrier.

Device

AMPLATZER TORQVUE DELIVERY SYSTEM W/PUSHER CATHETER
  • Modèle / numéro de série
    Model Catalog: (Lot serial: LOTS FAB. DEPUIS OCT 2003); Model Catalog: (Lot serial: LOTS FAB. DEPUIS OCT. 2003); Model Catalog: (Lot serial: LOT FAB DEPUIS OCT 2003); Model Catalog: (Lot serial: LOTS FAB DEPUIS OCT 2003); Model Catalog: (Lot serial: LOTS FABRIQUES DEPUIS OCT 2003)
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    AMPLATZER TORQVUE DS / PUSHER CATHETER
  • Manufacturer
    AGA MEDICAL CORPORATION

Manufacturer

AGA MEDICAL CORPORATION
  • Adresse du fabricant
    PLYMOUTH
  • 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