Events

Rappel de CardioVations (Heartport) EndoClamp Aortic Balloon Catheter 65 cm

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 Research Medical, 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
    53576
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0085-2010
  • Date de publication de l'événement
    2009-11-06
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85901
  • 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
    Vascular Clamp - Product Code DXC
  • Cause
    Spontaneous balloon rupture during use of the product.
  • Action
    Customers were notified by an Urgent - Product Recall letter, dated 9/29/09, and instructed to check their inventory, identify any unused product and return it to the company. Customers are to contact Customer Service Organization at 1-800-424-3278 to obtain a Returned Goods Authorization number, information concerning replacement product, and if they have any questions.

Device

CardioVations (Heartport) EndoClamp Aortic Balloon Catheter 65 cm
  • Modèle / numéro de série
    Model EC65 (codes are recorded in the following format: Lot #/Expiration date): 610810/Feb-10; 638667/Jun-10; 643626/Jun-10; and 651863/Aug-10.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US, Europe, Canada, Australia, and Thailand.
  • Description du dispositif
    EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter 65 cm,STERILE R, REF EC65, Edwards || Lifesciences LLC Irvine, CA 92614-5686" The device is a 10.5Fr wirewound, three-lumen catheter with a balloon near its tip for occluding the ascending aorta. || Indicated for use in patients undergoing cardiopulmonary bypass surgery. The catheter occludes the ascending aorta, vents the aortic root and allows || delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.
  • Manufacturer
    Edwards Lifesciences Research Medical, Inc.

Manufacturer

Edwards Lifesciences Research Medical, Inc.
  • Adresse du fabricant
    Edwards Lifesciences Research Medical, Inc., 6864 South 300 West, Midvale UT 84047
  • Société-mère du fabricant (2017)
    Edwards Lifesciences Corporation
  • Source
    USFDA