Events

Recall of SUCTION INSTRUMENTS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDTRONIC OF CANADA LTD..

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
    50207
  • Event Risk Class
    III
  • Event Initiated Date
    2017-07-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Medtronic has become aware that the specific lots of suction instruments are not able to pass instrument verification. instrument verification is a step in the software which is performed prior to the use of each instrument. this verification step confirms device tracking functionality and prevents use of the device if a passing verification is not achieved. the impacted devices were made with a particular stainless steel stock material that exhibits magnetic characteristics (magnetic permeability) causing interference with electromagnetic (em) tracking capability of the stealthstation. if this issue presents during surgery it may result in surgery being extended to troubleshoot the issue discontinuation of navigation or aborting surgery if alternative instruments are not available to proceed. there have been no reports of patient injury.

Device

SUCTION INSTRUMENTS
  • Model / Serial
    Model Catalog: 9734308 (Lot serial: 16062713)
  • Product Description
    SUCTION INSTRUMENTS
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Manufacturer Address
    BRAMPTON
  • 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
    HC