Events

Recall of NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit

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

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
    33451
  • Event Risk Class
    Class 2
  • Event Number
    Z-0339-06
  • Event Initiated Date
    2005-09-08
  • Event Date Posted
    2006-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41902
  • 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
    Device, Monitoring, Intracranial Pressure - Product Code GWM
  • Reason
    Certain model ns-p probes contained in the neurosensor cerebral blood flow and intracranial pressure monitoring kit may allow an intracranial pressure (icp) drift of up to ¿ 5 mmhg during the first 24 hours of monitoring icp. this is outside the products labeling specification of ¿ 2 mmhg maximum icp drift within the first 24 hours of monitoring.
  • Action
    Notify Customers and Sales Representatives who received the product by letter sent via Federal Express. Customers will be instructed that an Integra Sales Representative will contact them to arrange for return of affected product.

Device

NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit
  • Model / Serial
    W050708, W050980, & W050997
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    NeuroSensor Cerebral Blood Flow and Intracranial Pressure Monitoring Kit
  • Manufacturer
    Integra Neuro Sciences

Manufacturer

Integra Neuro Sciences
  • Manufacturer Address
    Integra Neuro Sciences, 5955 Pacific Center Blvd, San Diego CA 92121-4309
  • Source
    USFDA