Devices

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.
  • 1 Event

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