Events

Recall of Device Recall Aesculap 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
    70086
  • Event Risk Class
    Class 2
  • Event Number
    Z-1012-2015
  • Event Initiated Date
    2014-12-17
  • Event Date Posted
    2015-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132226
  • 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
    Some miethke shunt system accessories may have an incorrect mr safety symbol on the shelf box label. the label should have no symbol but instead is marked with the mr conditional symbol. the product is mr unsafe. this information is only required to be in the instructions for use (ifu).
  • Action
    Aesculap sent an Important Correction and Removal and Field Safety Notification letter, dated December 17, 2014, to all affected customers. The letter identiifed the affected product, problem, and actions to be taken. Customers were requested to remove from inventory and contact Aesculap regarding return of the affected devices and acknowledgement form.

Device

Device Recall Aesculap Miethke Shunt System
  • Model / Serial
    material numbers: FV400T FV401T FV402T FV403T FV404T FV405T FV406T FV407T FV408T FV409T FV499T FV790T FV791T FV792T FV793T FV794T FV795T FV796T
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    Miethke Shunt System accessories || Product Usage: - 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