VenaSeal Closure System

Manufacturer

  • 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
    MHRA

8 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model: SP-101, Affected: All lots
  • Manufacturer
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic VenaSeal Closure System Model SP-101
  • Manufacturer
  • Model / Serial
  • Product Description
    Disposable products
  • Manufacturer
  • Model / Serial
    Model no. SP-101, Lots, 35766, 36191, 36192, 36617, 36618, 37621, 37622, 37399, 37400, 38263, 38286, 38407, 38417, 38756, 38863, 38864, 39113, 39336, 39378, 39670, 39739, 39848 and 40075.; Model no. VS-301, Lots 34193, 35585, 37007, 38804, 39111, 39123, 39469 and 40160; Model no. VS-402, Lots 39970, 39971, 39972, 39973, 40067, 40069, 40187, 40243, 40271 and 40272.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution. No U.S. accounts; Australia, Canada, France, Germany, Hong Kong, Ireland, Italy, Latvia, Netherlands, Norway, Portugal, Switzerland, UAE and the United Kingdom.
  • Product Description
    VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
  • Manufacturer
3 more