Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet

Manufacturer

  • Manufacturer Address
    Covidien LLC, 60 Middletown Ave, North Haven CT 06473-3908
  • 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
    USFDA

2 devices with a similar name

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  • Model / Serial
    Catalog Number: 8888145048 8888145048C 8888145048CP 8888145049 8888145049C 8888145049CP 8888145050 8888145050C 8888145050CP 8888145057 8888145057C 8888145057CP 8888145062 8888145063 8888145066 8888145066C
  • Product Description
    Inactive implantable medical devices
  • Manufacturer