MO.MA ULTRA recallZ-0320-2024 · Medtronic Inc · initiated Oct 12, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
Medtronic issued an URGENT: MEDICAL DEVICE RECALL NOTIFICATION on 10/04/2023 via UPS. The notice explained the issue, potential risk, and requested the return of the device. For questions, consignees were directed to contact their Medtronic Field Sales Representative.
Recall details
- Recall number
- Z-0320-2024
- Status
- Open, Classified
- Initiated by the company
- Oct 12, 2023
- Posted by the FDA
- Nov 17, 2023
- Recalling firm
- Medtronic Inc
- Quantity
- 2767 units
- Product code
- NTE
- FDA submissions
- K092177
- Distribution
- Worldwide distribution - US Nationwide and the countries of Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom.
Product description
Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
Code information (models, lots, serial numbers)
UDI/DI 08033477090719: UDI/DI 00763000451691
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- MO.MA ULTRA MUS0130069X6Medtronic, Inc. · Temporary Carotid Catheter for Embolic Capture1 recall2 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K092177 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- MO.MA ULTRA MUS0130069X6Medtronic, Inc. · Temporary Carotid Catheter for Embolic Capture6 reports
- MO.MA ULTRA MUS0130069X6Medtronic, Inc. · Temporary Carotid Catheter for Embolic Capture1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 93258).
- Z-0321-2024 · Open, ClassifiedMedtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
- Z-0322-2024 · Open, ClassifiedMedtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130068X5
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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