Events

Recall of Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethke Shunt System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Aesculap, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68091
  • Event Risk Class
    Class 2
  • Event Number
    Z-1676-2014
  • Event Initiated Date
    2014-04-21
  • Event Date Posted
    2014-06-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126927
  • Notes / Alerts
    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.
  • Extra notes in the data
    Shunt, central nervous system and components - Product Code JXG
  • Reason
    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
  • Model / Serial
    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
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution including the states of PA, KY, NY, RI, SC, KS, TX, CT, TN and WA.
  • Product Description
    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.
  • Manufacturer Address
    Aesculap, Inc., 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA