Events

Recall of Channel Neuroendoscope, Standard Resolution, 21.6 cm. || Catalog No. 2232-001

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

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
    27299
  • Event Risk Class
    Class 3
  • Event Number
    Z-0049-04
  • Event Initiated Date
    2003-09-15
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29641
  • 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
    Size mix-up. 13 cm product may be labeled as 21.6 mm and visaversa.
  • Action
    Firm sales representatives will contact customers and hand deliver the recall notice.

Device

Channel Neuroendoscope, Standard Resolution, 21.6 cm. || Catalog No. 2232-001
  • Model / Serial
    A20284
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    TN, CO, GA and Japan
  • Product Description
    Channel Neuroendoscope, Standard Resolution, 21.6 cm. || Catalog No. 2232-001
  • Manufacturer
    Medtronic Neurosurgery

Manufacturer

Medtronic Neurosurgery
  • Manufacturer Address
    Medtronic Neurosurgery, 125 Cremona Drive, Goleta CA 93117
  • Source
    USFDA