SynchroMed II

  • Model / Serial
    8637-20, 8637-40 | All pumps manufactured From March 2005 through December 2010 and pumps manufactured with the previous battery design from January 2011 through June 2011
  • Product Description
    AIMD: General-purpose implantable infusion pump, programmable
  • Manufacturer
  • 1 Event


  • 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

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