OCTOPUS NUVO

  • Model / Serial
    Model Catalog: TSMICS1 (Lot serial: 2010040673 2010041500); Model Catalog: TSMICS1 (Lot serial: 2010061786)
  • Product Description
    OCTOPUS NUVO
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    BRAMPTON
  • Manufacturer Parent Company (2017)
  • 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

4 devices with a similar name

Learn more about the data here

  • Model / Serial
    TSMICS1 | see letter
  • Product Description
    MD: Patient positioning vacuum pad
  • Manufacturer
  • Model / Serial
    Lot #: 201002P030, 2010030795, 2010032195, 2010032196, 2010032690, 2010033377, 2010040102, 2010040103, 2010040673, 2010041001, 2010041500, 2010061786, 2010062722, 2010071111, 2010081105, 2010081987.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    within the US to: AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MS, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI and Washington D.C. OUS to include: Belgium, Canada, Germany, Italy, Poland, Switzerland, United Kingdom.
  • Product Description
    Medtronic Octopus Nuvo Tissue Stabilizer, model TSMICS1. The Octopus Nuvo Tissue Stabilizer is a disposable tissue stabilization system consisting of a rigid shaft, detachable tissue stabilizer headlink and a flexible articulating arm. The device is assembled within the thoracic cavity. Sterilized using ethylene oxide, non pyrogenic, disposable, single use only. || The product is intended to stabilize and minimize the motion of selected areas of the beating heart during minimally invasive cardiac surgery procedures under direct visualization through a thoracotomy.
  • Manufacturer
  • Model / Serial
  • Product Description
    Octopus Nuvo Tissue Stabilizer Model TSMICS1
  • Manufacturer