Events

Field Safety Notices about valitude crt-pvalitude crt-p (u125-u128); visionist crt-p models u225, u226, and u228; resonate crt-d models g424, g425, g426, g428, g437, g447, g448, g524, g525, g526, g528, g537, g547, g548; vigilant crt-d models g224, g225, g228, g237, g247, g248; momentum crt-d models g124, g125, g126, g128, g138; charisma crt-d models g324, g325, g328, g337, g347, g348; autogen crt-d models g160, g161, g166, g168 (us models), g172, g173, g175, g177, g179; dynagen crt-d models g150, g151, g156, g158; inogen crt-d models g140, g141, g146, g148; origen crt-d models g050, g051, g056, g058

According to Ministero della Salute (Health Ministry), this field safety notices involved a device in Italy that was produced by CARDIAC PACEMAKERA OWNED SUBSIDIARY OF GUIDANT CORPA OWNED SUBSIDIARY OF BOSTON SCIENTIFIC.

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
  • Event ID
    7804
  • Date
    2017-12-21
  • Event Country
    Italy
  • Event Source
    MSHM
  • Event Source URL
    http://www.salute.gov.it/portale/news/p3_2_1_3_1_1.jsp?lingua=italiano&menu=notizie&p=avvisi&tipo=dispo&id=7804
  • Notes / Alerts
    Italian data is current through August 2018. All of the data comes from Ministero della Salute (Health Ministry), 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 data from the U.S. and Italy.
  • Extra notes in the data
  • Action
    Safety instructions

Device

valitude crt-pvalitude crt-p (u125-u128); visionist crt-p models u225, u226, and u228; resonate c...

Manufacturer

CARDIAC PACEMAKERA OWNED SUBSIDIARY OF GUIDANT CORPA OWNED SUBSIDIARY OF BOSTON SCIENTIFIC
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    MSHM