Z-0321-2024Class II

Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6

Name: Z-0321-2024 Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
Creator: Medtronic Inc
Published: 2023-10-12
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2023-10-12 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Inc began a recall of Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6 on 2023-10-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0321-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-12
Posted: 2023-11-17
Recalling firm: Medtronic, Inc.
Product: Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM0130069X6
Product code: NTE Temporary Carotid Catheter For Embolic Capture
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 173 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.
Product codes and lots: UDI/DI 08033477090702:

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0321-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0320-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-17
Z-0321-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-17
Z-0322-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-17

Product code NTE

K092177Class IIMo.ma Ultra Proximal Cerebral Protection Device, Model Mus0130069x6Invatec S.P.A. / cleared 2009-10-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)