Events

Recall of Device Recall component of NeuroPort Array brain monitoring device.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by I2s Micro Implantable Systems Llc.

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
    55304
  • Event Risk Class
    Class 2
  • Event Number
    Z-1619-2010
  • Event Initiated Date
    2010-03-26
  • Event Date Posted
    2010-05-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90518
  • 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
    amplifier, physiological signal - Product Code GWL
  • Reason
    Component of cranial array may not allow sufficient tightening to maintain inserter position.
  • Action
    The firm, Blackrock Microsystems, sent a "RECALL" letter dated March 26, 2010, to all customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to discontinue use of all affected devices and promptly return any inventory, perform a physical account of your inventory for the recalled product and email a list of all serial numbers to Andrew Gotshalk at agotshalk@blackrockmicro.com, and to please email Andrew Gotshalk even if you do not have any inserter wand holders or have destroyed or removed from use the inserter wand holders. Blackrock will rework or replace all Inserter Wand Holders that is returned under this recall. If you have any questions regarding this recall please call 801-582-5533 x 275.

Device

Device Recall component of NeuroPort Array brain monitoring device.
  • Model / Serial
    Serial # 4273-0001 through 4273-0061
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: CA, MA, NY, RI, and UT.
  • Product Description
    Inserter Wand Holder, Non-Sterile, Serial # 4273-0000, Blackrock Microsystems, Salt Lake City, UT / or / Cyberkinetics Neurotechnology Systems, Inc., Salt Lake City, UT. || Intended use: The Inserter Wand Holder serves two key functions. It firmly secures the Inserter Wand to prevent recoil during the NeuroPort Array insertion process, and it facilitates precision alignment of the Inserter Wand with respect to the back of the NeuroPort Array just prior to pneumatic impulse insertion.
  • Manufacturer
    I2s Micro Implantable Systems Llc

Manufacturer

I2s Micro Implantable Systems Llc
  • Manufacturer Address
    I2s Micro Implantable Systems Llc, 391 Chipeta Way Ste G, Salt Lake City UT 84108-1264
  • Source
    USFDA