Device Recall Medtronic HMS PLUS, Hemostasis Management System

  • Model / Serial
    Catalogue Number 30514
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    All states in USA (Including DC) except RI and VT.
  • Product Description
    Medtronic HMS PLUS, Hemostasis Management System, Model 30514. || It is a microprocessor based, multichannel clot timing instrument with automated syringe handling for pipetting blood into single use cartridges. || It performs in vitro heparin sensitivity evaluations, heparin assays, activated clotting times and platelet function evaluations.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medtronic Inc, 710 Medtronic Pkwy, Minneapolis MN 55432-5603
  • 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