Events

Recall of HeartWare® HVAD Pumps in Inventory

According to Republic of Lebanon Ministry of Public Health, this recall involved a device in Lebanon that was produced by HeartWare.

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
  • Date
    2016-08-30
  • Event Country
    Lebanon
  • Event Source
    RLMPH
  • Event Source URL
    https://www.moph.gov.lb/userfiles/files/Medical%20Devices/Medical%20Devices%20Recalls%202016/30-8-2016/HeartWare.pdf
  • Notes / Alerts
    Lebanese data is current through July 2018. All of the data comes from the Ministry of Public Health (Republic of Lebanon), 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 Lebanon.
  • Extra notes in the data

Device

HeartWare® HVAD Pumps in Inventory

Manufacturer

HeartWare
  • 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
    RLMPH