Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6

Reason: The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation and deflation ports. Both sides of the complaint units manifold were labelled with the superior label leading to an incorrect identification of the proximal and distal inflation /deflation ports when viewing the devices from the inferior side.

Code information: UDI/DI 08033477090702:

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom.