Events

Rappel de Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt 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 Aesculap, 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
    68091
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1676-2014
  • Date de mise en oeuvre de l'événement
    2014-04-21
  • Date de publication de l'événement
    2014-06-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-10-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126927
  • 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
    Shunt, central nervous system and components - Product Code JXG
  • Cause
    Aic (usa) received information regarding 3 complaints in which the deflector did not move freely on the ventricular catheter.
  • Action
    Aesculap sent an Important Correction & Removal recall letter dated April 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. An Aesculap Sales Representative will contact you to schedule return of any affected inventory and replace your product. Please complete the attached Inventory Sheet which is necessary to comply with FDA regulations. When completing the inventory sheet, please be sure to fill in the quantity being returned. If you cannot locate the product, please provide an explanation as to why the inventory will not be returned (discarded, etc.). AIC (USA) appreciates your cooperation on this matter and apologizes for the inconvenience this may cause. Thank you for your patience and continued support of this product. Please contact (610) 984-9414 with any questions.

Device

Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System
  • Modèle / numéro de série
    Catalog No: FV431T, FV434T, FV433T, FV459T, FV078P, FV494T, FV676T, FV324T  Lot No: 4505150452,4505156642,4505164365,4505134636,4505150384,4505156634,4505246780,4505394315,4505150371,4505174213,4505187583,4505366616,4505134635,4505187582,4505134629,4505212089,4505199667,4505150340,4505171900,4505168804
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA.
  • Description du dispositif
    Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System || The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.
  • Manufacturer
    Aesculap, Inc.

Manufacturer

Aesculap, Inc.
  • Adresse du fabricant
    Aesculap, Inc., 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Société-mère du fabricant (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA