Events

Rappel de Device Recall EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS

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 Maquet Cardiovascular, 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
    55317
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1607-2010
  • Date de mise en oeuvre de l'événement
    2010-03-26
  • Date de publication de l'événement
    2010-05-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-04-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90545
  • 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
    prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
  • Cause
    This is an expansion of recall # z-866-2010, adding an additional two lots to the recall of exxcel soft stand wall eptfe vascular grafts due to a labeling mix up.
  • Action
    The firm, MAQUET Cardiovascular, LLC, sent a "DEVICE REMOVAL IMMEDIATE ACTION REQUIRED" letter dated March 23, 2010, to all customers via Federal Express. The letter describes the product, problem and action to be taken by customers. The customers were instructed to examine their stock immediately to determine if they have any of the affected product from the lot, discontinue dispensing the lot and complete and return by fax (973-709-6511) the enclosed Field Action Response Form whether or not they have any affected products. Please contact your local MAQUET cardiovascular sales representative or Customer Service at 1-888-880-2874 for the exchange.

Device

Device Recall EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS
  • Modèle / numéro de série
    UPN M002004948580; Lot 11407455, Exp 12/2010.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide distribution: USA including states of TX, NJ, SC, MO, ID, TN, FL, CA, PA and Canada and Germany.
  • Description du dispositif
    EXXCEL Soft Thin Wall EPTFE Vascular Graft; D:8 mm; L: 50 cm straight. || Sterile || Intended use: The Standard Wall EXXCEL and EXXCEL Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access. Wall Soft ePTFE Vascular Grafts are designed to repair or replace peripheral arteries.
  • Manufacturer
    Maquet Cardiovascular, LLC

Manufacturer

Maquet Cardiovascular, LLC
  • Adresse du fabricant
    Maquet Cardiovascular, LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Société-mère du fabricant (2017)
    Getinge AB
  • Source
    USFDA