Z-0321-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2023
- Initiation Date
- October 12, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 173 units
Product Description
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
Reason for Recall
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.
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.
Code Information
UDI/DI 08033477090702: