FDA Device recall Z-0320-2024
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
- 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 MUS0130069X6 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-0320-2024 |
| 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 MUS0130069X6
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 08033477090719: UDI/DI 00763000451691 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Other recalls by Medtronic
- Medtronic Sphere-9 Catheter, Model Number AFR-00001
FDA Device · Class II · 2026-05-06 · Medtronic - Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14…
FDA Device · Class II · 2026-01-21 · Medtronic - Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
FDA Device · Class II · 2025-12-10 · Medtronic - Medtronic CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Cobalt Crome application, Softw…
FDA Device · Class II · 2025-07-30 · Medtronic - Medtronic CareLink SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Cobalt Crome application, Sof…
FDA Device · Class II · 2025-07-30 · Medtronic
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0320-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.