Events

Field Safety Notices about FiberOptix Ultra 8 IAB

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 Arrow International Inc..

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
    2016-02-19
  • Event Country
    Slovenia
  • 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
    Arrow is recalling these products because of the possibility of separating the sleeve housing from the sleeve coupling. if separation occurs, there is a possibility of blood leaking from the preparation. if you do not take immediate action on blood leakage, a significant amount of blood loss or bleeding may occur. in addition, treatment delay, discontinuation, or loss of iab therapy may occur. arrow is recalling these series to provide customers and patients with the highest quality products.

Device

FiberOptix Ultra 8 IAB
  • Model / Serial
    FiberOptix Ultra 8 IAB: 8 Fr 30 cm3 IAB-05830-LWS FiberOptix Ultra 8 IAB: 8 Fr 30 cm3 IAB-05830-U FiberOptix Ultra 8 IAB: 8 Fr 40 cm3 IAB-05840-LWS FiberOptix Ultra 8 IAB: 8 Fr 40 cm3 IAB-05840-U 5800 Insert Tray in 6800 Series IAB IAK-06845 UltraFlex IAB: 7.5 Fr 30 cm3 IAB-06830-U Insert tray for IAB-S730C IAK-S7IT UltraFlex IAB: 7.5 Fr 40 cm3 IAB-06840-U RediGuard IAB: 7 Fr 30 cm3 IAB-S730C
  • Product Classification
    Cardiovascular Devices
  • Manufacturer
    Arrow International Inc.

Manufacturer

Arrow International Inc.