Events

Recall of Medtronic Neurosurgery C/n 3805-015 Peelaway Introducer Sheath, Disposable 15 F

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
    32595
  • Event Risk Class
    Class 2
  • Event Number
    Z-1111-05
  • Event Initiated Date
    2005-07-05
  • Event Date Posted
    2005-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40405
  • 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
    Cracked hubs/handles and/or improper peeling of the sheath during use.
  • Action
    Firm sent recall letters by Fedex on July 5, 2005 to all customers.

Device

Medtronic Neurosurgery C/n 3805-015 Peelaway Introducer Sheath, Disposable 15 F
  • Model / Serial
    Lots: A55754, A59282, A62361, A64132
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and to Canada, Australia, India, France, Italy, Netherlands, Portugal, South Africa, Spain, Switzerland, Turkey, United Kingdom.
  • Product Description
    Medtronic Neurosurgery C/n 3805-015 Peelaway Introducer Sheath, Disposable 15 F
  • Manufacturer
    Medtronic Neurosurgery

Manufacturer

Medtronic Neurosurgery
  • Manufacturer Address
    Medtronic Neurosurgery, 125 Cremona Dr, Goleta CA 93117-5503
  • Source
    USFDA