Events

Field Safety Notices about Occlutech® Occluder Set Inventory

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 Occlutech GmbH.

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
    2017-01-23
  • 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
    A customer inadvertently used an expired occlutech flex ll pusher cable and noticed doing so shortly after the implantation procedure. there was no impact on the patient, the procedure, or the product performance. occlutech occluders and compatible pusher cables are packaged together into an occlutech product set which also contains the instructions for use and the patient information card. the outer label on the occlutech product set clearly shows the expiration dates of both the occluder and the pusher cable. as these dates can differ from each other it is important to check both dates to not miss the shortest expiration date. .

Device

Occlutech® Occluder Set Inventory
  • Model / Serial
    All Lots/All Serial Numbers/All Sizes Occluders: Figulla Flex l ASD, Figulla Flex ll ASD, Figulla Flex l PFO, Figulla Flex ll PFO, Figulla Flexl UNI, Figulla Flex || UNI, Occlutech PDA Occluder, Occlutech PLD Occluder, Occlutech mVSD Occluder, Occlutech FASD Occluder All Lots/All Serial Numbers/All Sizes
  • Manufacturer
    Occlutech GmbH

Manufacturer

Occlutech GmbH