Events

Rappel de Device Recall Aesculap(R) 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
    63244
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0805-2013
  • Date de mise en oeuvre de l'événement
    2012-06-04
  • Date de publication de l'événement
    2013-02-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-01-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113098
  • 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
    The deflector may not move freely on the ventricular catheter. the deflector comes pre-positioned at the 5 cm mark on the catheter. in some cases the surgeon will want to adjust the deflector to a different location on the catheter before placing it in the ventricle. there is a small percentage of cases where aggressively attempting to adjust the deflector has a potential to cause the catheter.
  • Action
    Aesculap sent an Important Recall Notification letter dated June 4, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return the contact their local sales representative or customer service department at 1-800-282-9000 to return the affected product. Customers were also instructed to complete the Inventory Sheet attached to the letter with the quantity being returned. If customers could not locate the affected product they should provide an explanation as to why the inventory will not be returned. Customers with questions should call 610-984-9251 or 610-984-9291. For questions regarding this recall call 1-800-234-9179, ext 5067.

Device

Device Recall Aesculap(R) Miethke Shunt System
  • Modèle / numéro de série
    Lots 4503489878, 4503792749, 4503682927, 4503508385, 4503789879, 4503800248 and 4503682935.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including MI, PA and TX.
  • Description du dispositif
    Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide || Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) 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