Events

Recall of Device Recall AESCULAP (FH620R) MINOP InVent 30 Trocar System

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

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
    76769
  • Event Risk Class
    Class 2
  • Event Number
    Z-1814-2017
  • Event Initiated Date
    2017-03-07
  • Event Date Posted
    2017-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-02-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154132
  • 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
    Endoscope, neurological - Product Code GWG
  • Reason
    Aesculap implant systems llc is recalling the minop trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when removing the electrode.
  • Action
    On March 15, 2017, 16 facilities and 1 Sales Rep were sent an Urgent Medical Device Recall Notification letter. Letters were sent Fed-Ex overnight. Customers were asked to immediately discontinue use and quarantine the product. A Sales Representative will remove the affected product and return to Aesculap Inc.

Device

Device Recall AESCULAP (FH620R) MINOP InVent 30 Trocar System
  • Model / Serial
    Item # FH620R
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed throughout the United States and Canada.
  • Product Description
    AESCULAP MINOP InVent 30 Trocar System, non-sterile || Product Usage:The Minop InVent Trocar System intended use is for endoscopic procedures within the central nervous system, especially for the treatment of intra- and paraventricular pathological structures.
  • Manufacturer
    Aesculap Implant Systems LLC

Manufacturer

Aesculap Implant Systems LLC
  • Manufacturer Address
    Aesculap Implant Systems LLC, 3773 Corporate Pkwy, Center Valley PA 18034-8217
  • Manufacturer Parent Company (2017)
    Ludwig G. Braun Gmbh U. Co. Kg
  • Source
    USFDA