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Open, Classified

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

FDA Recall Z-0321-2024 · Posted 2023-11-17

Recalling FirmMedtronic Inc
Recall StatusOpen, Classified
Product CodeNTE
Date Initiated2023-10-12
Product Quantity173 units

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092177MO.MA ULTRA PROXIMAL CEREBRAL PROTECTION DEVICE, MODEL MUS0130069X6Invatec S.P.A. · 2009-10-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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