Events

Recall of Device Recall Medtronic PoleStar Intraoperative MRI system (N20 / N30)

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

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
    74464
  • Event Risk Class
    Class 2
  • Event Number
    Z-2129-2016
  • Event Initiated Date
    2016-06-20
  • Event Date Posted
    2016-07-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147636
  • 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
    System, nuclear magnetic resonance imaging - Product Code LNH
  • Reason
    Medtronic navigation is recalling certain components of the polestar system (n20 / n30) because of misplaced ground pins which may cause electrical shock to the user.
  • Action
    Medtronic sent a Field Safety Notice letter dated August 1, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that Medtronic will perform an inspection on site to verify and correct the grounding connection of the PoleStar System. For questions contact Medtronic Navigation Technical Services at 1-800-595-9709.

Device

Device Recall Medtronic PoleStar Intraoperative MRI system (N20 / N30)
  • Model / Serial
    Model No. 506A0107-01 & 506A0107-02 - Warning Lamps Control Box; 504A0276-01, 504A0277-01& 504A0278-01 - Warning Lamps Control Box Cables; 506A0297-01 & 506A0298-01 - Thermoflex Chiller
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide.
  • Product Description
    PoleStar system (N20 / N30) Warning Lamps Control Box, Warning Lamps Control Box Cables, Thermoflex Chiller || Product The PoleStar Surgical MRI System is intended for use as an intraoperative imaging device to produce MRI images of sections of the head selected by the physician.
  • Manufacturer
    Medtronic Navigation

Manufacturer

Medtronic Navigation
  • Manufacturer Address
    Medtronic Navigation, Kochav Yokneam, 1 Hamelacha St., Yokne'am Ilit Israel
  • 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