Lower riskMedical device recall · FDA · Published October 12, 2023
Medtronic Mo.Ma Ultra Device Recall: Incorrect Port Labeling Risk
Medtronic recalls Mo.Ma Ultra Proximal Cerebral Protection Device model MOM0130069X6 due to incorrect port labeling that could lead to improper use during medical procedures.
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.
“Medtronic Mo.Ma Ultra Device Recall: Incorrect Port Labeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57078-medtronic-mo-ma-ultra-device-recall-incorrect-port-labeling-risk. Based on FDA recall #Z-0321-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0321-2024%22&limit=1).
The FDA announced on 2023-10-12 that Medtronic Inc. is voluntarily recalling its Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6, due to mislabeling hazards. The error may lead to incorrect identification of inflation and deflation ports during use.
Distribution: Worldwide, including US Nationwide and Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom
The hazard
According to the FDA, the device manifold was labeled with two stickers, an inferior and superior sticker, one on each side. Both sides of the complaint units' manifold were labeled with the superior label, leading to incorrect identification of the proximal and distal inflation/deflation ports when viewing the devices from the inferior side.
Context
GovInfoNow's records show Medtronic, Inc. has 38 other recalls on record since 2017-09-10. Recent brand recalls include the 2026-03-11 Sphere-9 Catheter Recall for risk of ventricular fibrillation and the 2025-12-04 Abre Venous Stent Recall for potential stent migration. Other recent recalls of similar products include the 2026-05-12 Medtronic Octopus 4 Tissue Stabilizer Model 29400 Recall for incorrect tubing assembly and the 2026-08-18 Baxter Healthcare PRO+ 40" MRS SURFACE Mattress Recall for incorrect labeling risk.
How to tell if you have this one
Check for the model number MOM0130069X6 on the device. The device was sold with a specific UDI/DI code 08033477090702.
Brand
Medtronic
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the countries of Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom.
Recall number
Product, codes & lots
Quantity
Z-0320-2024
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6; UDI/DI 08033477090719: UDI/DI 00763000451691
2767 units
Z-0321-2024
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6; UDI/DI 08033477090702:
173 units
Z-0322-2024
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5; UDI/DI 08033477090696:
48 units
Based on the official FDA remedy
What to do — step by step
Check Device Labels
Look for the model number MOM0130069X6 and UDI/DI code 08033477090702 on the device.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 48 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0321-2024 (October 12, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0321-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.