Events

Recall of Medtronic IN.Pact Amphirion Drug-Eluting Balloon (DEB)

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Invatec Technology Centre GmBH.

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
    15634
  • Event Initiated Date
    2013-11-12
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
  • Reason
    Based on data from the in.Pact deep clinical study manufacturer has decided to recall and stop supplying the in.Pact ampirion drug-eluting balloon as it did not meet its safety and efficacy end points relative to the percutaneous transluminal angioplasty (pta) control. the study also identified a potential safety signal given a trend towards an increased rate of major amputations in the deb study arm.
  • Action
    Product to be returned to supplier

Device

Medtronic IN.Pact Amphirion Drug-Eluting Balloon (DEB)

Manufacturer

Invatec Technology Centre GmBH
  • 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
    NZMMDSA