Events

Recall of Device Recall Reveal LINQ insertable Cardiac Monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73494
  • Event Risk Class
    Class 2
  • Event Number
    Z-1249-2016
  • Event Initiated Date
    2016-02-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144301
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Detector and alarm, arrhythmia - Product Code DSI
  • Reason
    Medtronic has identified an issue with the sensitivity of an algorithm used in the reveal linq icm that may prematurely trigger the recommended replacement time (rrt) alert in some devices. battery capacity is not affected and the device will continue to support data collection and manual data transmissions. as part of the normal behavior of the device, 30 days after rrt status is reached, reveal.
  • Action
    Consignees in US were hand delivered a Medtronic "Medical Device Correction" letter dated February 2016. The letter was addressed to Physician or Healthcare Professional. The letter described the Issue & Patient Management Guidance. For questions contact your local Medtronic Representative or Medtronic Diagnostic Technical Services at 800-929-4043. Outside the U.S., the letter will be mailed or hand delivered to impacted consignees.

Device

Device Recall Reveal LINQ insertable Cardiac Monitor
  • Model / Serial
    All Reveal LINQ ICM, Model LNQ11 serial numbers are impacted. Medtronic continues to manufacture and distribute Reveal Ll NQ devices.
  • Product Classification
    Cardiovascular Devices
  • 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
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • Manufacturer Address
    Medtronic Inc., 8200 Coral Sea St Ne, Saint Paul MN 55112-4391
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • 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