Events

Rappel de Device Recall Powerlink (R) System with IntuiTrak Delivery 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 Inc.

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
    53983
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0594-2010
  • Date de mise en oeuvre de l'événement
    2009-11-25
  • Date de publication de l'événement
    2010-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-05-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86997
  • 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
    Catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
  • Cause
    This action is being taken because the product has the potential for the polyimide tubing to detach from the inner core due to the bond failure. if this occurs, treatment may be delayed or interrupted. the firm's initial health hazard analysis indicated the event may cause temporary or medically reversible adverse health consequences or an outcome where the probability of serious adverse health.
  • Action
    The recall communication was initiated on 11/25/09 by phone call and followed by recall letter via Fed-Ex Overnight. The recall letter informed the consignees of the reason for recall and products affected. Users were instructed to share this information with physicians that performed the affected procedures at their facility. Endologix informed their consignees that their personnel would retrieve the affected devices and return it to Endologix at no cost and would replace the affected units. Consignees with questions or comments about the notice are directed to (800) 983-2284.

Device

Device Recall Powerlink (R) System with IntuiTrak Delivery System
  • Modèle / numéro de série
    MODEL NUMBER 34-34-80LE, LOTS W09-2967 AND W09-3000.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Recalled devices were distributed to medical centers and hospitals in OR, PA, FL, TX, MI and LA.
  • Description du dispositif
    Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967 AND W09-3000.
  • Manufacturer
    Endologix Inc

Manufacturer

Endologix Inc
  • Adresse du fabricant
    Endologix Inc, 11 Studebaker, Irvine CA 92618-2013
  • Source
    USFDA