Medtronic Inc Recall 93258
Description: Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
Medtronic Inc Recall 93258 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0321-2024 |
| Event ID | 93258 |
| Event Description | Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide and the countries of Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom. |
| Quantity | 173 units |
| Recall 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. |
| Device Classification | 20231129 |
| Device Code Info | UDI/DI 08033477090702: |
| Center Classification Date | 20231117 |
| Recall Initiation Date | 20231012 |
| Recalling Firm | Medtronic Inc |
| Initial Notification | Letter |
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