Events

Recall of Device Recall NeuroBalloon

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

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
    56190
  • Event Risk Class
    Class 1
  • Event Number
    Z-2425-2010
  • Event Initiated Date
    2010-07-02
  • Event Date Posted
    2010-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92899
  • 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
    neurovascular catheter - Product Code HAO
  • Reason
    Certain neuroballoon catheters have the potential to improperly inflate or deflate under certain conditions.
  • Action
    All customers and Integra Sales Specialists were notified of the recall on July 2, 2010 by fax, e-mail and letter send by Fed Ex overnight delivery.

Device

Device Recall NeuroBalloon
  • Model / Serial
    Catalog number: 7CBD10, lot numbers: 1057983, 0158170, 0158391, 0158587, 0158739, 0159085, 0159411, 0159499, 0159938, 0161630, and 0161857.
  • Product Classification
    Neurological Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada, Taiwan and to Integra, Australia.
  • Product Description
    Integra NeuroSciences Implants, NeuroBalloon Catheter, || Sterile/EO, Rx only, single use, latex free: Catalog Number 7CBD10
  • Manufacturer
    Integra LifeSciences Corp

Manufacturer

Integra LifeSciences Corp