Recall of STIMPOD NMS 410

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by TELEFLEX MEDICAL CANADA 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
    132378
  • Event Risk Class
    III
  • Event Initiated Date
    2014-05-07
  • Event Country
  • 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
    It has come to the manufacturer's attention that in isolated incidences the user continues to use the device if the keypad has been broken or is damaged. the damage to the keypad could possibly be caused by wear and tear the ingress of aggressive cleaning solutions or by abuse such as pressing the buttons with sharp objects like a pen tweezers or long finger nails. this could cause the internal circuitry of the keypad to become exposed which could potentially lead to an electric shock if the keypad and the electrodes are handled simultaneously. the occurrence of such phenomena is not a direct malfunction of the device but rather due to negligence.

Device

  • Model / Serial
    Model Catalog: XT-41001-NA (Lot serial: NA); Model Catalog: XT-45011-NA (Lot serial: NA)
  • Product Description
    STIMPOD NMS410
  • Manufacturer

Manufacturer