Recall of Device Recall Medtronic Instrument Set EM ENT

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Status
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Ear, Nose, and Throat Stereotaxic Instrument - Product Code PGW
  • Reason
    The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
  • Action
    Medtronic sent an Urgent Medical Device Recall letter dated June 25, 2017, via overnight mail on June 29, 2017, to all affected customers. Letters to foreign customers are being handled by geography-specific Regulatory Specialists. Customers were instructed examine their inventory for the affected product and immediately quarantine them for return for Medtronic. Customers with affected product were instructed to contact Medtronic Technical Services at 1-800-595-9709 to receive a return material authorization (RMA) and arrange for their return and no charge replacements. Customers were asked to complete and follow instructions on the attached Consignee Response Form. Sign and date the bottom of the form and then return the form to Medtronic at RS or fax it to Medtronic Technical Services at 651-367-7075. Customers with questions were instructed to call 1-800-595-9709.


  • Model / Serial
    Each of the devices within the kit are labeled with information specific to each of the reusable devices within the kit and those devices are what goes into the customer inventory. The outer box where the lot number is printed is discarded by the customer on receipt and the separate devices within the box are what is stored on the shelf. Therefore, no kit lot number is being provided.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Canada.
  • Product Description
    Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved Suction, and 9733451, 90 deg Curved Suction. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. || The suction devices are part of a family of reusable ENT instruments that are used with the StealthStationTM AxiEM surgical navigation system. The AxiEM system is an electromagnetic (EM) tracking solution for surgical tools. The system measures an induced voltage created by local magnetic fields from a set of coils in the transmit coil array (TCA). Each surgical tool has a set of receiving coils to sense the magnetic field strength. Using a mathematical algorithm, the position and orientation of the instrument can be computed and overlaid/registered to imagery on a computer monitor, resulting in the ability to track the instrument tip in relation to the patients anatomy. AxiEM ENT Suction devices are used as suction and pointing devices. The suction devices are intended to have an ENT Instrument Tracker mounted on it
  • Manufacturer


  • Manufacturer Address
    Medtronic Navigation, Inc., 826 Coal Creek Cir, Louisville CO 80027-9710
  • Manufacturer Parent Company (2017)
  • 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