Events

Recall of GEM II DR

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
    48621
  • Event Risk Class
    II
  • Event Initiated Date
    2000-02-16
  • 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
    Loss of telemetry and device output because of fractured solder joint.

Device

GEM II DR
  • Model / Serial
    Model Catalog: 7273 (Lot serial: PJK200606H PJK200989H); Model Catalog: 7273 (Lot serial: PJK202209H PJK200857H); Model Catalog: 7273 (Lot serial: PJK200853H PJK201834H); Model Catalog: 7273 (Lot serial: PJK200322S PJK200611H); Model Catalog: 7273 (Lot serial: PJK200174H PJK200214H); Model Catalog: 7273 (Lot serial: PJK200743S PJK201835H); Model Catalog: 7273 (Lot serial: PJK200522S PJK200607H); Model Catalog: 7273 (Lot serial: PJK200346S PJK200521S); Model Catalog: 7273 (Lot serial: PJK200762S PJK200768S); Model Catalog: 7273 (Lot serial: PJK200415S PJK200305S); Model Catalog: 7273 (Lot serial: PJK201838H PJK201883H); Model Catalog: 7273 (Lot serial: PJK200424S PJK201837H); Model Catalog: 7273 (Lot serial: PJK200520S PJK201922H); Model Catalog: 7273 (Lot serial: PJK200310S PJK200524S); Model Catalog: 7273 (Lot serial: PJK200526S PJK200528S); Model Catalog: 7273 (Lot serial: PJK201815H PJK202178H); Model Catalog: 7273 (Lot serial: PJK200323S PJK200696S)
  • Product Description
    GEM DR II
  • 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