Events

Rappel de Device Recall Edwards EndoReturn Arterial Cannula, model ER21B and ER23B

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
    65744
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1972-2013
  • Date de mise en oeuvre de l'événement
    2013-07-16
  • Date de publication de l'événement
    2013-08-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120020
  • 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, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Cause
    Edwards lifesciences is recalling certain lots of the endoreturn arterial cannula that were built with an incorrect component. this component can create a performance problem with the intraclude intraaortic occlusion device.
  • Action
    Edwards sent an Urgent Field Safety Notice letter dated July 16, 2013 via Fed-Ex. The letter identified the affected product, problem and action to be taken. The letter included a Customer Acknowledgement Form to be completed and faxed to 800-422-9329 Attn: Recall Coordinator. If the customer does not send back the acknowledgement form, two additional contacts are made to notify the customer and request return of affected product. This is tracked by Edwards customer service and reported each week. Customer were requested to assess their inventory to assure that all affected product is identified and returned. Returned products will be destroyed. For questions call Edwards Customer Service at 800-424-3278.

Device

Device Recall Edwards EndoReturn Arterial Cannula, model ER21B and ER23B
  • Modèle / numéro de série
    Model ER21B Lots: 59496984, 59516933, 59516936, 59531385, 59531386 , 59543708   Model ER23B Lots: 59464327, 59484349, 59484350, 59484351, 59512146, 59513272, 59516940, 59534430, 59535739, 59541763
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide including Canada and VA sites.
  • Description du dispositif
    Edwards EndoReturn Arterial Cannula, model ER21B and ER23B || Product Usage: || The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector hub. The ThruPort catheter introducer sheath kit includes a wire reinforced cannula with hemostasis valve, an introducer, and a guidewire. The cannulae have a wire reinforced section to provide kink resistance and flexibility, tapered tips to aid in insertion and advancement into the femoral artery, a non-reinforced clamp site, a 3/8 in. (9.5 mm) barbed connector, and a hemostasis valve (available on some versions) that allows passage of catheters, such as the EndoClamp aortic catheter. The introducers accept a .038 in. (0.97 mm) guidewire and are marked to simplify assembly and indicate alignment. On some versions, a connector hub secures and immobilizes the introducer within the cannula for easier, one person insertion of the cannula/introducer assembly.
  • Manufacturer
    Edwards Lifesciences, LLC

Manufacturer

Edwards Lifesciences, LLC
  • Adresse du fabricant
    Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, Draper UT 84020-9414
  • Société-mère du fabricant (2017)
    Edwards Lifesciences Corporation
  • Source
    USFDA