Recall Or Safety Alert for Intravascular catheter kits "ICY" for heat exchange, originally manufactured by ZOLL Medical; External cables of the JARVIK 2000 Ventricular Assist System; Separately offered screws and plates for the JARVIK 2000 Ventricular Assist system; Foam protectors added by IST CARDIOLOGY to the JARVIK 2000 Ventricular Assist System, but not provided by the manufacturer JARVIK HEART Inc.; Batteries for the operation of the JARVIK 2000 Ventricular Assist System; Endotracheal intubation tubes "ECOM", originally manufactured by CONMED Corporation; Dual lumen Bi-caval cannulae, originally manufactured by AVALON Laboratories, LLC. (AV 10013, AV 10016, AV 10019, AV 10020, AV 12100); Connectors for bi-caval cannulae with dual lumen with the marking AVALON

According to Austrian Federal Office for Safety in Health Care (BASG), this recall or safety alert involved a device in Austria that was produced by N/A.

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
  • Event Country
  • Event Source
  • Event Source URL
  • Notes / Alerts
    Austrian data is current through September 2018. All of the data comes from the Austrian Federal Office for Safety in Health Care (BASG), 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 Austria.
  • Extra notes in the data


  • Source