• 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
  • 1 Event

One device in the database

  • Model / Serial
    TRELLIS 6 and TRELLIS 8, models BVT608010, BVT608030, BVT612010, BVT612030, CVT808015, CVT808025, || CVT812015, CVT812025, EVT808015, EVT808025, || EVT812015V01 and EVT812025V01, specific lots
  • Product Classification
  • Product Description
    The TRELLIS peripheral infusion system is designed for the controlled and selective infusion of liquids, includingtrolyolitics, inside the peripheral vasculature.