Field Safety Notices about HeartMate ll® System Controller, Model 105109

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Abbott Laboratories.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
  • Event Country
  • Event Source
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    As follow-up to our most recent communication in september, 2015, we are advising you that thoratec corporation, an abbott laboratories company, is updating its alert guides, conducting a software upgrade and adding controller alignment markings for the heartmate ii® system controller as part of a continued effort to ensure patients are successfully able to exchange their pocket controller in emergency situations. a number of training and education improvements were completed in 2014 upon a voluntary field correction regarding the patient controller exchange process. as a result, we saw an 80% reduction in adverse event rates for system controller exchanges, and a 90% shift of system controllers being exchanged at home to being completed in the hospital, which is consistent with the instructions for use. despite this, patients continue to experience a very low level of adverse events (including serious injury or death), at a rate of o. 1%, as a result of unnecessary patient controller exchanges. system controller exchanges are best conducted by medical professionals in a controlled environment. .



  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source