Events

Rappel de Device Recall AFX Endovascular AAA System

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Endologix.

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
    76106
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1054-2017
  • Date de mise en oeuvre de l'événement
    2016-12-27
  • Date de publication de l'événement
    2017-01-19
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-04-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152168
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    System, endovascular graft, aortic aneurysm treatment - Product Code MIH
  • Cause
    Endologix updated the instructions for use (ifu) and implemented modifications to the afx endovascular aaa system (afx system).
  • Action
    A Dear Physician letter dated 6/2/15 was sent to customers to inform them of the 2014 Clinical Update on the Endologix Endovascular Systems for AAA Repair. The letter provided update on the clinical programs and commercial experience (i.e., post-market surveillance). On January 2016, a Dear Physician letter was sent to customers to inform them of the 2015 Clinical Update covering the Endologix Endovascular Systems for AAA Repair. The letter provided update reports for the cumulative clinical data and commercial experience (i.e., post-market surveillance) of the Powerlink System and the AFX Endovascular AAA system and contains important information and recommendations regarding the continued safe and effective use of the devices. On 12/27/2016 a Dear Physician letter provides important information related to the AFX Endovascular AAA System (AFX System). The letter informs the customers that a series of updates to the Instructions for Use (IFU) and modifications to the product were implemented, including introduction of a graft material processing improvement known as Duraply. Customers with any questions are instructed to contact their Endologix representative.

Device

Device Recall AFX Endovascular AAA System
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    US, and worldwide: Austria, Belgium, Czech Republic, France, Germany, Greece, Ireland, Israel, Italy, Latvia, Luxembourg, Monaco, Netherlands, Poland, Portugal, Spain, Sweden, Switzerland, Turkey, United Kingdom.
  • Description du dispositif
    AFX Endovascular AAA System, Endoleak Type IIIB || Common Name: AFX Bifurcated and Accessory Stent Grafts || Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
  • Manufacturer
    Endologix

Manufacturer

Endologix
  • Adresse du fabricant
    Endologix, 35 Hammond, Irvine CA 92618-1607
  • Société-mère du fabricant (2017)
    Endologix Inc.
  • Source
    USFDA