Events

Field Safety Notices about STATLOCK® IAB STABILIZATION DEVICE

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 MAQUET.

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
    2016-05-09
  • 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
    It was discovered during post-quarantine packaging on february 16, 2016 that the ifu for the statlock sheath stabilization device for percutaneous sheath introducers (see illustration 1, statlock for psi ifu on this page) was erroneously packaged with the mega and sensation plus iab catheter kits, instead of the ifu for the statlock catheter stabilization device for iab catheters (see illustration 2, statlock for iab ifu on this page). .

Device

STATLOCK® IAB STABILIZATION DEVICE
  • Model / Serial
  • Manufacturer
    MAQUET

Manufacturer

MAQUET
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    AMPMDRS