Events

Recall of Device Recall Vycor Medical ViewSite Brain Access System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vycor Medical, 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
    63319
  • Event Risk Class
    Class 1
  • Event Number
    Z-0673-2013
  • Event Initiated Date
    2012-08-21
  • Event Date Posted
    2013-01-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113513
  • 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
    Retractor, self-retaining, for neurosurgery - Product Code GZT
  • Reason
    Vycor medical recalled their vbas (vycor viewsite brain access system) because an unidentified black fiber was found on the device.
  • Action
    Vycor Medical, Inc. notified all customers of the product recall by telephone and follow-up letter. Customers were instructed to quarantine affected products and hold the shipment(s) in quarantine unti further notice. The units will be replaced with inspected and passed units. All distributors were instructed to notify their customers of the recall and ask to have them return their stock. For question call 561-558-2020.

Device

Device Recall Vycor Medical ViewSite Brain Access System
  • Model / Serial
    Model # TC171105 Lot # VM83450
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (Nationwide) in the states of TX, IL, NJ, FL, OH, PA and (International) in the country of Japan.
  • Product Description
    Vycor Medical ViewSite Brain Access System 17mm/ 11mm / 5cm Device***STERILE*** || Product Usage: || The Vycor Viewsite Brain Access System (VBAS) has been designed to serve as a self-retaining retractor system for brain tissue. It is comprised of an introducer and a working channel port that are secured by a spring-loaded latch. Each device allows for the gentle retraction of tissue, visualization of the surgical site and for the smooth manipulation of introduced instruments. The range of device sizes (width and length) provides various working channel sizes.
  • Manufacturer
    Vycor Medical, Inc.

Manufacturer

Vycor Medical, Inc.
  • Manufacturer Address
    Vycor Medical, Inc., 6401 Congress Ave Ste 140, Boca Raton FL 33487-2841
  • Manufacturer Parent Company (2017)
    Vycor Medical, Inc.
  • Source
    USFDA