FDA Device recall Z-0322-2024
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
- FDA Device
- Class II
- ongoing
- Published 2023-11-29
On 2023-11-29 the FDA classified a Class II recall of Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5 by Medtronic, citing 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 (CC….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0322-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-12 |
| Published | 2023-11-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic |
| Distribution | US |
Product
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
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.
Identifiers
| code_info | UDI/DI 08033477090696: |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0322-2024%22
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