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 is recalling a specific cerebral protection device model because its port labels are incorrectly placed. This could cause improper use during medical procedures if the device is not properly aligned.
The device has two stickers labeling the balloon inflation and deflation ports. If the superior sticker is on both sides, the ports could be misidentified when viewed from the inferior side. This might lead to improper use during medical procedures.
Medical professionals using the device for procedures involving cerebral protection are most at risk. Patients receiving this device during surgery may also be affected if misaligned.
Check for the model number MOM0130069X6 on the device. The device was sold with a specific UDI/DI code 08033477090702.
Look for the model number MOM0130069X6 and UDI/DI code 08033477090702 on the device.
The recall is for incorrect labeling that could lead to improper use, not for danger when used correctly.
Check for the model number MOM0130069X6 and UDI/DI code 08033477090702 on the device.
The recall does not specify a remedy, so contact Medtronic for further instructions.
We’ve drafted a message you can send Medtronic to request your refund or repair — edit it as you like.
Subject: Recall Z-0321-2024 — Medtronic Medtronic Hello, I own a Medtronic that is covered by recall Z-0321-2024 from Medtronic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
