Events

Recall of Device Recall Aesculap Miethke Shunt System, miniNAV Valve

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
    69741
  • Event Risk Class
    Class 3
  • Event Number
    Z-0814-2015
  • Event Initiated Date
    2014-11-11
  • Event Date Posted
    2014-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-06-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131451
  • 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
    Aesculap inc. (aic (usa)) initiated a recall of miethke shunt system accessories due to missing patients' labels for the mininav (fv660t). there are no patient injuries resulting from this issue.
  • Action
    An important correction & removal notification, dated November 11, 2014, was sent to consignees that identified the product, problem, and action to be taken. Consignees were asked to complete the distribution inventory sheet and return it. Aesculap sales representatives would be coordinating pick up of affected devices.

Device

Device Recall Aesculap Miethke Shunt System, miniNAV Valve
  • Model / Serial
    Catalog No: FV660T Lot No: 4506022655
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in OK, and WI.
  • Product Description
    Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) 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