Field Safety Notices about Target Nano

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 Stryker Neurovascular.

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
    2016-03-06
  • Event Country
  • Event Source
    AMPMDRS
  • 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
    Stryker neurovascular has noticed that some target nano products lack adequate tensile strength. joints within the coil providing tensile strength may have been damaged during production, which may lead to increased coil stretching.

Device

  • Model / Serial
    M0035442540 M0035421520 M0035431520 M0035452530 M0035452040 M0035442040 M0035421030 M0035431030 M0035452060 M0035453060 M0035421540 M0035431020 M0035443560 M0035452540 M0035453040 M0035421530 M0035431010 M0035443040 M0035453080 M0035452030 M0035442030 M0035431540 M0035443060 M0035452560 M0035431510 M0035421020 M0035431530 M0035452020
  • Manufacturer

Manufacturer

  • Manufacturer Parent Company (2017)
  • Source
    AMPMDRS