FlexCath Advance Steerable Sheath

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
    BAM

4 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic FLexCath Advance Steerable Sheath
  • Manufacturer
  • Model / Serial
    4FC12 | All
  • Product Description
    MD: Haemostasis valve
  • Manufacturer
  • Model / Serial
    FlexCath Advance Steerable Sheath(Medtronic Australasia Pty Ltd - FlexCath Advance 4FC12 - Catheter introducer, haemostasis valve)Model Number: 4FC12All Lot NumbersARTG Number: 213965
  • Manufacturer