Events

Rappel de Device Recall Marquet Heartstring II Proximal Seal 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 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
    56868
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0940-2011
  • Date de mise en oeuvre de l'événement
    2010-05-05
  • Date de publication de l'événement
    2011-02-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94744
  • 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
    Clamp, vascular - Product Code DXC
  • Cause
    Deployment tube may detach during use due to insufficient adhesive, which may result in product failure to operate.
  • Action
    The firm, MAQUET Getinge Group, sent an "URGENT DEVICE REMOVAL IMMEDIATE ACTION REQUIRED" letter dated May 5, 2010, to all customers via Federal Express. The letter described the product, problem and actions to be taken by the customer. The customers were instructed to immediately examine their stocks to determine if they have any of the affected product, if found, discontinue dispensing (distributing) the lot and complete the Field Action Response Form; immediately contact accounts if they acted as a distributor, and acknowledge receipt of this notification whether or not they have any affected products by completing the Field Action Response Form via fax to (U.S.): 1-888-899-2874. If you have any additional questions, please contact your local MAQUET Cardiovascular sales representative or our Customer Service at 1-888-880-2874.

Device

Device Recall Marquet Heartstring II Proximal Seal System
  • Modèle / numéro de série
    Lot numbers 12895788, 12946718, 25002866, 25004647, 13029141, 25005045, 25005622
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Japan, Mexico, Germany, Switzerland, Israel
  • Description du dispositif
    Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular, Wayne, NJ || Intended use: medical device for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.
  • 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