Events

Recall of Device Recall Medtronic Passive Planar Blunt Probe

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

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
    71278
  • Event Risk Class
    Class 2
  • Event Number
    Z-1794-2015
  • Event Initiated Date
    2015-05-05
  • Event Date Posted
    2015-06-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137215
  • 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
    Neurological stereotaxic Instrument - Product Code HAW
  • Reason
    Passive planar blunt probe (lot# 150223) was manufactured with a sharp tip rather than a blunt tip.
  • Action
    Medtronic sent an Medical Device Safety Alert letter dated May 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken by the user: "Examine your inventory and if any of the affected products are found, please quarantine them for return to Medtronic. "A Medtronic representative will follow-up to arrange for removal and replacement. If you have any questions regarding this action, please contact Medtronic Navigation Technical Services at 1-800-595-9709.

Device

Device Recall Medtronic Passive Planar Blunt Probe
  • Model / Serial
    lot number 150223
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : CA, MO, LA and PA., and Internationally to Ireland.
  • Product Description
    Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically tracked, reusable instrument used in navigated surgery and is included with Medtronic cranial instrument kits. It is designed for use in patient registration and palpating brain tissue during surgical procedures.
  • Manufacturer
    Medtronic Navigation, Inc.

Manufacturer

Medtronic Navigation, Inc.
  • Manufacturer Address
    Medtronic Navigation, Inc., 826 Coal Creek Cir, Louisville CO 80027-9710
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA