FDA Medical Device Recalls (openFDA)
Medtronic Inc: Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
- Recall number
- Z-0320-2024
- Recalling firm
- Medtronic Inc
- Product
- Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MUS0130069X6
- Status
- Open, Classified
- Initiated
- 2023-10-12
- Posted
- 2023-11-17
- Terminated
- not on file
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 2767 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom.
- Lot, serial or model codes
- UDI/DI 08033477090719: UDI/DI 00763000451691
- 510(k) numbers
- ["K092177"]
- PMA numbers
- not on file
- Product code
- NTE
- Firm FEI
- 3001504994
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28