Events

Rappel de Device Recall Edwards LifeStent FlexStar selfexpanding bilary stent 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 Edwards Lifesciences, Llc.

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
    45436
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0179-2008
  • Date de mise en oeuvre de l'événement
    2007-03-19
  • Date de publication de l'événement
    2007-11-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-03-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65468
  • 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
    Bilary stent system - Product Code FGE
  • Cause
    Failure to deploy.
  • Action
    This recall was executed by an Urgent-Product Recall letter dated March 15, 2007, which was delivered via overnight service to the affected accounts on 3/19/07. In addition, the affected sales force was notified by Email and given a copy of the recall letter. The sales force was asked to assist in retrieval of the product. The letter advises that one lot of the Edwards LifeStent FlexStar Bilary Stent System -- Model EX080801CD; 8 MM x 80 MM stent, 80 CM delivery system, Lot FR6K0319 may exhibit incidences of failure to deploy and is being recalled. Customers are advised to check their inventory for lot #FR6K0319 and remove all unused product from stock. Product is to be returned or it will be retrieved. The letter also advises that if the product has been implanted, there is no need to inform the patient of this notification as this is solely related to the delivery system and the characteristics of the stent are not affected in any way. Either the customer or the sales representatives will return written notification of the status of product from this lot which had been shipped.

Device

Device Recall Edwards LifeStent FlexStar selfexpanding bilary stent system
  • Modèle / numéro de série
    Model EX080801CD; Lot FR6K0319
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide including states of OK, GA, CA WI, MO, and LA
  • Description du dispositif
    Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model EX080801CD; 8 MM x 80 MM stent, 80 CM Delivery System, Lot FR6K0319, Edwards Lifesciences, LLC., Irvine, CA 92614
  • Manufacturer
    Edwards Lifesciences, Llc

Manufacturer

Edwards Lifesciences, Llc
  • Adresse du fabricant
    Edwards Lifesciences, Llc, 1 Edwards Way, Irvine CA 92614-5688
  • Source
    USFDA