Medtronic Mo — Class II medical device recall Z-0321-2024
Ongoing recall by Medtronic Inc, reported 2023-11-29, distributed nationwide. The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each sid
| Recall number | Z-0321-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc, Minneapolis, MN, United States |
| Recall initiated | 2023-10-12 |
| Classified | 2023-11-17 |
| Reported by FDA | 2023-11-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | CH, DE, DZ, ES, FR, GB, IQ, IT, JP, NL, PL, RO, SE |
| Quantity | 173 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 08033477090702 |
| Model numbers | MOM0130069X6 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0321-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.