Recall of Device Recall N'Vision software Application Card

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

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    pump, infusion, implanted, programmable - Product Code LKK
  • Reason
    Routine monitoring of medtronic's vigilance program identified user related programming errors. medtronic has received reports of both overdose and underdose that were the result of programming use of synchromed implantable infusion pumps. these errors were most commonly associated with: --priming bolus programming; and --bridge bolus programming. pump programming errors that result in overdos.
  • Action
    Medtronic is exchanging 8870 versions AAG, AAJ and BBG and replacing it with the updated versions AAH01 and BBH01. The updated versions contain user interface improvements to reduce the chance of user related programming errors when programming SynchroMed II and SynchroMed EL Infusion Pump system. A Medtronic "Medical Device Correction" letter was left behind for consignees. The letter was addressed to "Healthcare Provider" and was dated February 2009. The letter provided information regarding changes to the programming software used in SynchorMed Infusion System. For additional information, please contact your Medtronic Representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.


  • Model / Serial
    All model 8870 application cards version AAG, AAJ (English only US & Japan) & BBG (Multi-Language OUS)
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    All States in the US including DC. OUS: Austria Belgium Croatia Cyprus Czech Republic Denmark Estonia Faroe Islands Finland France French Polynesia Germany Greece Hungary India Ireland Israel Italy Kuwait Lebanon Malta Martinique Netherlands New Caledonia Norway Poland Portugal Reunion Russian Federation San Marino Saudi Arabia South Africa Spain Sweden Switzerland Turkey United Kingdom Vatican City State Canada Mexico Brasil
  • Product Description
    Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician Programmer. Manufactured for: Medtronic, Inc., Minneapolis, MN 55432-5604 USA.
  • Manufacturer


  • Manufacturer Address
    Medtronic Neuromodulation, 7000 Central Ave NE, Minneapolis MN 55432-3568
  • 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