CoreValve AccuTrak Delivery Catheter 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
    SMPA

4 devices with a similar name

Learn more about the data here

  • Model / Serial
    Models DCS-C4-18Fr and DCS-C4-18Fr-23
  • Product Description
    Intended to deliver CoreValve Transcatheter Aortic Valve, which is designed to treat severe aortic valve stenosis without open-heart surgery or surgical removal of the native valve.
  • Manufacturer
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Medtronic CoreValve AccuTrak Delivery Catheter System
  • Manufacturer
  • Model / Serial
    CoreValve AccuTrak Delivery Catheter System (DCS) (Intended to deliver CoreValve Transcatheter Aortic Valve, which is designed to treat severe aortic valve stenosis without open-heart surgery or surgical removal of the native valve)Models DCS-C4-18Fr and DCS-C4-18Fr-23Supplied in Australia under the Clinical Trial Notification (CTN) and Authorised Prescriber Schemes
  • Manufacturer