SynchroMed® II Implantable Drug Infusion Pump


  • 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

10 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model 8637 (20 ml and 40 ml) ......................... FDA update code : All SynchroMed II pumps are affected
  • Product Description
    Infusion Pump
  • Manufacturer
  • Model / Serial
  • Implanted device?
  • Product Description
    Active implantable medical devices - drug pumps
  • Manufacturer
5 more