Events

Recall of Device Recall 13.5 mm x 60 mm BrainPath Sheath

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nico 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
    62588
  • Event Risk Class
    Class 2
  • Event Number
    Z-2201-2012
  • Event Initiated Date
    2012-07-17
  • Event Date Posted
    2012-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111099
  • 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
    Brainpath sheaths were mislabeled. sheaths which measure 50mm were labeled as 60mm. the length callout on the label does not match the actual length of the sheath within the packaging resulting in an improper fit as further explained below. this mislabeling was discovered on 29-june-2012 during a clinical case.
  • Action
    NICO Neuro and Spine sent an Urgent Recall letter to all affected customers on July 18, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to complete the recall response form. Affected sheaths distributed within the US will be obtained and discarded by NICO. Affected sheaths shipped to Canada will be obtained and discarded by NICOs distributor, Galen Medical. For questions customers should call 888-632-7071.

Device

Device Recall 13.5 mm x 60 mm BrainPath Sheath
  • Model / Serial
    REF: NN-8012 - LOT: 80345-TD00214 (manufactured on 11-April-2012)
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including MI and Canada
  • Product Description
    13.5 mm x 60 mm BrainPath Sheath || The NICO BrainPath is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths (three lengths available for each: 50mm, 60mm, and 75mm). The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues.
  • Manufacturer
    Nico Corp.

Manufacturer

Nico Corp.
  • Manufacturer Address
    Nico Corp., 12263 Bridgewater Rd, Indianapolis IN 46256-9428
  • Manufacturer Parent Company (2017)
    NICO Corp
  • Source
    USFDA