REVEAL LINQ INSERTABLE CARDIAC MONITOR

Manufacturer

  • Manufacturer Address
    BRAMPTON
  • 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
    HC

8 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model: LNQ11, Affected:
  • Manufacturer
  • Model / Serial
    All Reveal LINQ ICM, Model LNQ11 serial numbers are impacted. Medtronic continues to manufacture and distribute Reveal Ll NQ devices.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including DC and the countries of Andorra, Australia, Austria, Belgium, Botswana, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Faroe Islands , Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Namibia, Netherlands, New Caledonia, New Zealand, Norway, Oman, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tanzania, Thailand, Turkey, United Arab Emirates and United Kingdom.
  • Product Description
    Reveal LINQ insertable Cardiac Monitor, Model LNQ11. || Monitors subcutaneous ECG continuously.
  • Manufacturer
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Active implantable medical devices - measuring devices and sensors
  • Manufacturer
  • Model / Serial
    LNQ11
  • Product Description
    AIMD: Implantable cardiac monitor
  • Manufacturer
3 more