Events

Recall Or Safety Alert for Shelhigh BioConduit™ stentless valve, Shelhigh BioMitral™ tricuspid valve, Shelhigh BioRing™ (annuloplasty ring), Shelhigh Gold™ perforated patches, Shelhigh Injectable Pulmonic Valve System, Shelhigh Internal Mammary Artery, Shelhigh MitroFast® Mitral Valve Repair System, Shelhigh No-React® Dura Shield, Shelhigh No-React® EnCuff Patch, Shelhigh No-React® Pericardial Patch, Shelhigh No-React® PneumoPledgets, Shelhigh No-React® VascuPatch, Shelhigh No-React® Stentless Valve Conduit, Shelhigh No-React® Tissue Repair Patch/UroPatch™, Shelhigh NR2000 SemiStented™ aortic tricuspid valve, Shelhigh NR900A tricuspid valve, Shelhigh Pericardial Patch, Shelhigh Pre Curved Aortic Patch (Open), Shelhigh Pulmonic Valve Conduit No-React® Treated

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 Shelhigh Inc..

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
    2007-04-19
  • Event Country
    Austria
  • Event Source
    BASG
  • Event Source URL
    https://www.basg.gv.at/en/medical-devices/official-announcements/
  • 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

Device

Shelhigh BioConduit™ stentless valve, Shelhigh BioMitral™ tricuspid valve, Shelhigh BioRing™ (ann...

Manufacturer

Shelhigh Inc.
  • Source
    AFOSHCBASG