Events

Recall Or Safety Alert for STATLOCK® Fixation Device for Intraaortic Balloon (BIA) included in MEGA® Intra-Aortic Balloon Catheter and SENSATION PLUS® Intra-Aortic Fiber-Optic Balloon Catheter

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain that was produced by Maquet.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Recall / Safety Alert
  • Date
    2016-06-06
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Extra notes in the data
  • Action
    Possibility that certain batches of insertion kits of BIA MEGA® and SENSATION PLUS® catheters containing the STATLOCK® intraaortic balloon (BIA) fixation device, manufactured by Maquet, USA, contain the instructions for use of the fixation device STATLOCK® for percutaneous introducer (PSI).

Device

STATLOCK® Fixation Device for Intraaortic Balloon (BIA) included in MEGA® Intra-Aortic Balloon Ca...
  • Model / Serial
  • Manufacturer
    Maquet

Manufacturer

Maquet
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    AEMPSVFOI