Medical Devices

Medtronic Mosaic Aortic Prosthesis


The Agency for Medicinal Products and Medical Devices (HALMED) has received a notice from the manufacturer Medtronic Inc. on the change of the iEOA table and size measuring device for Mosaic aortic bioprosthesis of the model 305 due to reports to higher than expected transvalvular gradients occurred after implantation.

The manufacturer has informed users that older versions of tables and measuring device will not be distributed anymore.

Here you may view the safety information addressed to users.