Recall of (3) Amplia MRI CRT-D series (DTMC 2 QQ Compia MRI Quad CRT-D series) (2) Amplia MRI CRT-D series (DTMB 2 QQ Amplia MRI Quad CRT- D IS4 / DF4)

According to Pharmaceuticals and Medical Devices Agency, Japan, this recall involved a device in Japan that was produced by Japan Medtronic Co., Ltd..

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
  • Date
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Japanese data is current through August 2018. All of the data comes from the Japanese Pharmaceuticals and Medical Devices Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Japan.
  • Extra notes in the data


  • Model / Serial
  • Product Description
    "(1) Programmer for implanted active equipment" "(2) (3) Implantable biventricular pacing pulse generator with defibrillation function"
  • Manufacturer


  • 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