# FDA recall Z-0322-2024

> **Medtronic Inc** · Class II · device recall initiated 2023-10-12.

## Product

Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5

## 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

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

## Key facts

- **Recall number:** Z-0322-2024
- **Recalling firm:** Medtronic Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-12
- **Report date:** 2023-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0322-2024

## Citation

> AI Analytics. FDA recall Z-0322-2024. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-0322-2024. Source: US FDA. Licensed CC0.

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