Events

Rappel de Device Recall Elana Surgical KitHUD

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 Elana, 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
    75632
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0698-2017
  • Date de mise en oeuvre de l'événement
    2016-11-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150965
  • 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
    Surgical Kit - Product Code PAX
  • Cause
    Elana has issued this field action to voluntarily remove specific serial numbers of our elana surgical kithud due to potentially compromised integrity of the outer sterile packaging of the elana catheter 2.0.
  • Action
    Elana sent an Urgent Medical Device Recall letter dated November 7, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to not use the affected device and to return the product for replacement. Customers were also instructed to complete the attached Acknowledgement and Receipt Form to facilitate the product return and exchange. Customers with questions were instructed to call 301-215-7010.

Device

Device Recall Elana Surgical KitHUD
  • Modèle / numéro de série
    Manufacturers Product Number, 801-H  Lot/Serial Number, 160301
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    HDE
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including NY and Internationally to Switzerland and the Netherlands.
  • Description du dispositif
    Elana Surgical KitHUD || The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity
  • Manufacturer
    Elana, Inc.

Manufacturer

Elana, Inc.
  • Adresse du fabricant
    Elana, Inc., 10480 Little Patuxent Pkwy Ste 400, Columbia MD 21044-3576
  • Source
    USFDA