Events

Recall of STRATA NSC LUMBOPERITONEAL SHUNT KIT

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
    122217
  • Event Risk Class
    II
  • Event Initiated Date
    2017-03-03
  • 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
    The adjustable mechanism in the strata device allows the physician to non-invasively adjust the valve's pressure/performance level (pl) using a magnetic adjustment tool included with the strata adjustment kit or with the stratavarius system. accumulation of biological debris within the valve adjustment mechanism may inhibit the free rotation of the valve magnet when exposed to 3t mri and may become reverse polarised. this may result in discrepancies between the pressure level readings on the strata indicator tool or stratavarius system.

Device

STRATA NSC LUMBOPERITONEAL SHUNT KIT
  • Model / Serial
    Model Catalog: 44420 (Lot serial: >100 nunbers contact mfg); Model Catalog: 46836 (Lot serial: >100 nunbers contact mfg); Model Catalog: 42355 (Lot serial: >100 numbers contact mfg); Model Catalog: 42866 (Lot serial: >100 nunbers contact mfg); Model Catalog: 42856 (Lot serial: >100 nunbers contact mfg); Model Catalog: 44430 (Lot serial: >100 nunbers contact mfg); Model Catalog: 44421 (Lot serial: >100 nunbers contact mfg); Model Catalog: 46871 (Lot serial: >100 nunbers contact mfg); Model Catalog: 46876 (Lot serial: >100 nunbers contact mfg); Model Catalog: 46881 (Lot serial: >100 nunbers contact mfg); Model Catalog: 46886 (Lot serial: >100 nunbers contact mfg); Model Catalog: 27820 (Lot serial: >100 nunbers contact mfg); Model Catalog: 27821 (Lot serial: >100 nunbers contact mfg); Model Catalog: 46635 (Lot serial: >100 nunbers contact mfg); Model Catalog: 42365 (Lot serial: >100 numbers contact mfg); Model Catalog: 27818 (Lot serial: >100 nunbers contact mfg); Model Catalog: 27819 (Lot serial: >100 nunbers
  • Product Description
    Strata NSC Lumboperitoneal Shunt Kit;Strata Burr Hole Shunt Assembly;Strata Valve;Strata II Valve;Strata II Unitized Shunt Kit;Strata NSC Burr Hole Shunt Assembly;Strata II Shunt Assembly with Bioglide;Strat II Snap Shunt Assembly;Strata II Valve with Bio
  • 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